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Background Four-component meningococcal B (4CMenB) vaccine is licensed in many countries but has had limited use in adolescents despite this age group being at increased risk of meningococcal disease. Objectives To assess the safety profile of two doses of 4CMenB in adolescents. Methods Cluster randomised controlled trial of senior school students in South Australia (SA) with participating schools randomised to intervention (4CMenB) or control. Vaccine safety was monitored using the South Australian Vaccine Safety Surveillance System (SAVSS), a spontaneous reporting system for adverse events following immunisation (AEFI) with enhanced follow-up of AEFI. Results 58,637 doses of 4CMenB vaccine were administered to 30,522 students (median age 16 years) during 2017–2018. Of 18,348 and 12,174 students vaccinated in 2017 and 2018, 97.3% and 84.3%, respectively, received both scheduled doses (N = 28,115). 193 AEFI in 187 students were reported with a reporting rate of 0.32% (95%CI: 0.28–0.39%). Seventy individuals sought medical review, including nine serious adverse events. 98% (166/169) of those who were contactable for AEFI follow-up (87.6% 169/193) reported resolution of the event. Most common AEFI were injection site reaction (126/193), headache (99/193) and nausea (61/193). AEFI were more frequently reported in females (aOR = 1.409 (95%CI: 1.002, 1.980)), schools with high level of educational advantage (adjusted Odds Ratio (aOR) = 1.515 (95%CI: 1.005, 2.284)), following first dose (aOR = 1.619 (95%CI: 1.168, 2.244)), and in 2017 (aOR = 1.437 (95%CI: 1.001, 2.064)). Reported AEFI declined with increasing age (aOR = 0.771 (95%CI: 0.673, 0.883)). Conclusion In this largest post-licensure use of 4CMenB in adolescents, the low AEFI reporting rate provides real-world evidence of 4CMenB safety in this age group. (ClinicalTrials.gov number: NCT03089086).

Infants are at the highest risk of severe complications - including death - as a result of pertussis infection. Controlling pertussis in this group has been challenging, particularly in those too young to be vaccinated. Following revised national recommendations in March 2015, the state of New South Wales, Australia, introduced a funded maternal vaccination campaign at 28 - 32 weeks of gestation using a 3-component tetanus-diphtheria-acellular pertussis vaccine (dTpa; Boostrix, GSK). This study aimed to assess the effectiveness of maternal vaccination and add to the growing body of evidence for this strategy.A 1:1 matched case-control study was conducted between 16 August 2015 and 17 August 2016. Cases were laboratory or doctor notified, laboratory confirmed (nucleic acid testing or culture) and aged6 months at onset. Each control infant was randomly selected from public hospital births in the same geographical area in the period up to 3 days before and after the case's birthdate. Odds ratios (OR) were calculated using conditional logistic regression. Vaccine effectiveness (VE) was calculated as 1 - OR.In total, 117 cases and 117 controls were recruited. The overall VE estimate was non-significantly protective for infants6 months old (VE 39%, 95% CI -12 to 66%). Higher VE was observed for infants3 months old (VE 69%, 95% CI 13-89%) and against hospitalisation (VE 94%, 95% CI 59-99%).Maternal pertussis vaccination with a 3-component acellular vaccine was found to be highly effective at preventing severe disease in infants, but was less effective at preventing disease which did not require hospitalisation. The overall VE reported in this study was lower than in prior studies and suggests that maternal vaccination, while an effective strategy at preventing severe pertussis, is less effective at protecting against infection or mild disease.

Background Australia is one of only a few countries with a long-standing and consistent serosurveillance program. We conducted a national serosurvey in 2012–2013 to estimate population seroprevalence of measles-specific IgG and the effective reproduction number, R, and compare the results with the three previous serosurveys (1996–1999, 2002 and 2007) to examine trends following a decade of sustained measles control. Methods 2729 residual sera from 1 to 49 year olds were tested using the Enzygnost anti-measles IgG enzyme immunoassay (EIA). All sera in the equivocal range by EIA on re-testing and a random sample of low positive and negative sera were later tested by a microneutralisation assay. R was calculated from weighted estimates of the proportion seronegative by age using a previously developed contact matrix. Results In the 2012–13 serosurvey, anti-measles IgG seropositivity for 1–49 year olds was 80.8% (95% CI: 79.4–82.3%) and 8.9% (95% CI: 7.8–10.0%) had equivocal antibody levels. The increasing proportion of seronegative and equivocal individuals in age groups 10–39 years continued a trend seen in previous serosurveys. There was also an increase in equivocal results among 2–4 and 5–9 year old children, >90% of whom were recently vaccinated. R increased from 0.57 in 1999 to above the epidemic threshold of 1 in 2012–13 (R = 1.7). All 20 EIA negative sera, 238/241 (98.8%) equivocal sera, and 89/92 (96.7%) low positive sera had a titre Conclusions A number of countries with sustained measles control have now demonstrated that measles-specific IgG antibodies decline with time since vaccination. As there is good epidemiologic evidence of population-level protection, the implications of declining measles-specific IgG antibody levels for maintaining measles elimination are unclear. Novel studies to determine correlates of protection against measles transmission and disease in the post-elimination era are needed to help answer this question.

There are limited long-term data on seroprevalence of neutralising antibody (nAb) to the three poliovirus serotypes following the switch from oral polio vaccine (OPV) to inactivated polio vaccine (IPV). In Australia, combination vaccines containing IPV replaced OPV in late 2005. Using serum and plasma specimens collected during 2012 and 2013, we compared prevalence of nAb to poliovirus type 1 (PV1), type 2 (PV2) and type 3 (PV3) in birth cohorts with differing IPV and OPV eligibility from an Australian population-based sample. In the total sample of 1673 persons aged 12 months to 99 years, 85% had nAb against PV1, 83% PV2 and 67% PV3. In the cohort 12 to18 years (eligible for 4 OPV doses, last dose 8-14 years prior), a significantly lower proportion had nAb than in the 7 to12 year cohort (eligible for 3 OPV doses and an IPV booster, last dose 3-8 years prior) for all poliovirus types: [PV1: 87.1% vs. 95.9% (P = 0.01), PV2: 80.4% vs. 92.9% (P = 0.003) and PV3: 38.1% vs. 84.0% (P 0.0001)]. These data suggest individual-level immunity may be better maintained when an OPV primary schedule is boosted by IPV, and support inclusion of an IPV booster in travel recommendations for young adults who previously received only OPV.

INTRODUCTION Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. METHODS Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey. Retrospective data from 2 years were combined to examine specific AEFI rates, particularly fever and medical attendance as a proxy for serious adverse events (SAE), with and without concomitant vaccine administration. As trivalent influenza vaccines (TIV) were funded in Australia's National Immunisation Program (NIP) in 2015 and quadrivalent (QIV) in 2016, respectively, we compared their safety profiles. RESULTS 7402 children were included. Data were reported weekly through each vaccination season; no safety signals or excess of adverse events were detected. More children who received a concomitant vaccine had fever (7.5% versus 2.8%; p

Introduction Post-partum vaccination of new mothers is currently recommended in Australia to reduce pertussis infection in infants. Internationally, vaccination recommendations now include pregnant women in some countries. Understanding the awareness of pertussis vaccination recommendations among pregnant women, and their willingness to have the vaccine while pregnant is important for informing vaccine program implementation. Objective To determine awareness and intentions toward current recommendations for post-partum pertussis vaccination among Australian pregnant women, and their willingness to accept pertussis vaccine during pregnancy, should it be recommended in Australia in the future. Design Quantitative self-administered survey, using a non-random stratified sampling plan based on representative proportions by age, parity and region of residence. Participants and setting Pregnant women receiving antenatal care through three large, demographically diverse referral hospitals in metropolitan, urban and rural New South Wales, Australia. Results The response rate was 815/939 (87%). Most women (80%) reported willingness to have the pertussis vaccine during pregnancy, should it be recommended. Thirty four per cent of women intended to receive a pertussis vaccine post-partum, 17% had received it previously, while 45% had never heard of pertussis vaccine, had not thought about it, or were undecided about having it. Compared with those who had not received a recommendation to have the vaccine post-partum, women who had received a recommendation were 7 times more likely (95% CI 4–14) to report intention to have the vaccine. Conclusions Health care provider recommendation is paramount to raising awareness of pertussis vaccination recommendations among pregnant women. Women's willingness to have the vaccine while pregnant is encouraging, and indicates the potential for high pertussis vaccine coverage among pregnant women, should it be recommended in Australia.

Background In November 2005, Australia introduced a publicly funded single dose of varicella vaccine for children aged 18-months. We describe the impact of this program on varicella hospitalisations in Queensland and provide the first assessment of single-dose varicella vaccine effectiveness in Australia since the program commenced. Methods Age-standardised varicella hospitalisation rates were calculated for 2000–2014 and pre- and post-public funding period rates compared. Case-control studies were conducted to investigate the association between vaccine receipt and both varicella hospitalisations and uncomplicated varicella emergency department presentations. Cases were matched to controls from a population-based register by date of birth and state of residence. Vaccine effectiveness was calculated as (1 – odds ratio) × 100%. Results Compared to the pre-funded period (2000–2003), age-standardised varicella hospitalisation rates declined by more than 70% in 2011–2014 with varicella principal diagnosis rates declining from 5.7 to 1.6 per 100,000 population per year. Varicella vaccine effectiveness at preventing hospitalisation with a principal diagnosis of varicella among children aged 19-months to 6-years was 81.9% (95% confidence interval: 61.8–91.4%), while for emergency department presentations among children aged 19-months to 8-years it was 57.9% (95% confidence interval: 48.5–65.5%). Conclusions In Australia, the single-dose varicella vaccination program has substantially reduced varicella morbidity. The single-dose varicella vaccine schedule is moderately-to-highly effective against hospitalisation, but appears less effective against emergency department presentations.

This study evaluates the evidence for elimination of rubella and congenital rubella syndrome (CRS) in Australia, drawing on three national serosurveys conducted between 1996 and 2007 and supported by statutory notification and vaccine coverage data. Anti-rubella IgG seropositivity was defined as ≥ 10 IU/ml by EIA. Between 1998 and 2007, rubella notifications fell >100-fold, to an average of 2 cases per million and there were five confirmed cases of CRS, two of which were locally acquired in 2003. Weighted overall seropositivity remained constant among 1-49 year-olds (89.6% in 1999; 88.1% in 2007). Between 2002 and 2009, 95% of children received at least one dose of the measles-mumps-rubella (MMR) vaccine. All three serosurveys provided estimates for R less than 0.5, well below the epidemic threshold of 1. All available data are supportive of Australia being considered for elimination status. Further reductions in incidence of CRS will require continued attention to vaccine coverage in overseas-born women, as well as the maintenance of current high coverage level of two-dose MMR vaccination.

We compared the results of two national serosurveys in Australia to evaluate the impact of universal infant vaccination and school-based programs for adolescents. Immunity improved significantly overall, especially in 1-year-olds (40.0% versus 86%; p0.0001); in adolescents it was significantly higher in regions with established school-based programs (56.6% versus 38.8%; p=0.0008). 6.1% of 1-59-year-olds were positive for HBcAb and 0.7% for HBsAg. We have demonstrated successful implementation of universal infant hepatitis B vaccination in Australia and that school-based programs for adolescents are effective. This experience should be applicable to low prevalence countries in northern Europe which have not implemented universal hepatitis B immunisation.

Objective This paper examines how the monovalent varicella vaccine for children, with an adolescent catch-up dose, was introduced into Australia's National Immunisation Program (NIP), focusing on programme implementation. Methods Semi-structured interviews were conducted with key informants involved in programme implementation. Key themes from interviews were identified through content analysis. Childhood coverage was assessed using data from the Australian Childhood Immunisation Register (ACIR) with adolescent coverage obtained from state/territory immunisation programmes. Seroprevalence data were analysed from national serosurveys conducted before and after programme commencement. Results Implementation challenges for both parents and providers included: (a) parental report of previous infection as an exclusion criterion; (b) introducing a vaccine on its own at 18 months of age; and (c) adding the adolescent dose into existing school-based vaccination programmes with parental reported exclusion criteria. Despite these challenges, coverage rapidly reached 83% by 24 months of age and 30–33% for the adolescent catch-up dose. When considered in conjunction with estimated pre-vaccination natural immunity in both target groups (20% and 83%, respectively) coverage can be considered high. The serosurvey under-estimated coverage in 2-year-old children but was useful to assess trends in population immunity. Conclusion The introduction of a single dose of monovalent varicella vaccine at 18 months of age and a school-based catch-up programme at 11–13 years of age successfully achieved high coverage, notwithstanding some challenges. Reported natural infection has been an exclusion criterion for vaccination, but as the programme matures and circulation of wild-type virus decreases, the need for this warrants consideration. There is a need for sensitive laboratory assays to measure vaccine-induced immunity at a population level.

Abortion, resulting from infections by the parasite Neospora caninum, is a major cause of economic loss to both the dairy and beef industries of cattle-producing countries of the world. Vaccination as a means of preventing abortion and/or infection represents a viable control strategy; indeed a commercial vaccine is available in some countries, albeit of unknown efficacy. The commercial vaccine is based on inactivated tachyzoites of N. caninum but other approaches based on lysates and recombinant antigens of N. caninum may also be feasible. In this study we have used an immunisation/challenge model of transplacental transmission, based on the Qs mouse with an Nc-Liverpool challenge, to investigate the vaccine potential of a number of formulations based on four recombinant proteins of N. caninum (GRA1, GRA2, MIC10, and p24B). All formulations studied were immunogenic in the mouse when assessed by ELISA using sonicated tachyzoite antigen as the target antigen. In one experiment, a mixture of MIC10 and p24B produced partial protection against transplacental transmission of N. caninum in this mouse model; in contrast a live infection of tachyzoites of NC-Nowra given before pregnancy always induces very high levels of protective immunity. The field of vaccines against Neospora-associated abortion in cattle is discussed. © 2008 Elsevier Ltd. All rights reserved.

Notification trends from countries with well-established immunisation programs show increasing tetanus cases among the elderly, corresponding to seroepidemiologic data showing declining immunity with advanced age. We examined Australian trends in tetanus to review the likely value of routine funded immunisation at 65 years. Since 1993, 62% (36/58) of notifications, 44% (67/151) of hospitalisations and 83% (10/12) of deaths were in people aged over 65 years. Taking into account higher vaccine coverage at 65 years, versus the current recommended age in Australia of 50 years, we estimate that routine funded tetanus vaccine would prevent 9% more hospitalisations and 28% more deaths than the most favourable outcome from the current unfunded recommendation at 50 years. This is likely to be applicable to other industrialised countries.