[ESCULAPIO: A project to elaborate strategies and actions of multi-purpose health communication on vaccine preventable infectious diseases in order to increase vaccination coverage in the population]. / Progetto ESCULAPIO: Elaborazione di Strategie e di interventi di Comunicazione sanitaria mUlti-obiettivo sulle maLAttie infettive Prevenibili e sulle vaccInazioni come mezzo per aumentare le cOperture vaccinali nella popolazione.

ESCULAPIO Project, funded by the Centre for Disease Prevention and Control (CCM) of the Italian Ministry of Health, for the program 2013, aims at increasing awareness on vaccine preventable infectious diseases (VPID) and vaccination in different targets of population and at spreading the culture of prevention by the development of information/training interventions on VPID. In Tuscany Region (Central Italy), educational courses on VPID in high schools were organized and students were stimulated to prepare informative materials on VPID for lower grade school pupils. Educational games for school pupils were realized in Liguria Region (Northern Italy) with the aim to increase awareness and knowledge of vaccination among primary school children, their families, and teachers. The Sicilian Operative Unit (OU) developed and validated a questionnaire to collect data on the main factors influencing vaccine uptake in a population from Southern Italy and spreading information on vaccines to the general population. Aim of the activities performed in Apulia Region (Southern Italy) was to collect, directly from the public, a set of issues to which people were more "sensitive," in order to perceive the dimension of informative needs and the misinformation in the field of vaccinations. A toll-free telephone line to answer questions on VPID was also the aim of the Apulian activities. The objective of the OU of Sardinia (Southern Italy) was to increase knowledge on VPID and adherence to immunization campaigns in health care workers (HCW) by realizing traditional and e-learning training courses and initiatives of health promotion in healthcare and hospital setting. Interventions to promote vaccinations in maternal and child health services and outreach interventions in case of parental non-compliance with vaccination schedules were performed in the Veneto Region (Northern Italy), with the aim to reach a particular subgroup of the general population: new or future parents. The activities of Veneto Region aimed also at realizing individual interviews with parents and/or home visit, if considered useful, for families not respondents to the active ordinary call.

Adjuvanted influenza vaccine for the Italian elderly in the 2018/19 season: an updated health technology assessment.

BACKGROUND: The elderly, defined here as subjects aged ≥ 65 years, are among at-risk subjects for whom annual influenza vaccination is recommended. For the 2018/19 season, three vaccine types are available for the elderly in Italy: trivalent inactivated vaccine (TIV), adjuvanted TIV (aTIV) and quadrivalent inactivated vaccines (QIV). No health technology assessment (HTA) of seasonal influenza vaccination in the elderly has previously been conducted in Italy. METHODS: An HTA was conducted in 2017 to analyze the burden of influenza illness, the characteristics, efficacy, safety and cost-effectiveness of available vaccines and the related organizational and ethical implications. This was then contextualized to the 2018/19 influenza season. Comprehensive literature reviews/analyses were performed and a static mathematical model developed in order to address the above issues. RESULTS: In Italy, influenza is usually less common in the elderly than in other age-classes, but the burden of disease is the highest; >10% of infected elderly subjects develop complications, and about 90% of all influenza-related deaths occur in this age-class. All available vaccines are effective, safe and acceptable from an ethical standpoint. However, aTIV has proved more immunogenic and effective in the elderly. Furthermore, from the third payer's perspective, aTIV is highly cost-effective and cost-saving in comparison with TIV and QIV, respectively. Nevertheless, vaccination coverage needs to be improved. CONCLUSIONS: According to this HTA, aTIV appeared the vaccine of choice in the elderly. HTA should be reapplied whenever new relevant data become available.

Heterogeneous estimates of influenza virus types A and B in the elderly: Results of a meta-regression analysis.

Influenza has many age-dependent characteristics. A previous systematic review of randomized controlled trials showed that the detection rate of influenza B was higher in children than in non-elderly adults. However, no comprehensive reviews have targeted the elderly, who carry the main burden of disease. We aimed to quantify the relative detection rates of virus types A and B among the elderly, to identify factors affecting these proportions, and to compare type distribution among seniors and younger age-classes. A comprehensive literature search was conducted to identify multiseason studies reporting A and B virus type distributions in the elderly. A random-effects meta-analysis was planned to quantify the prevalence of type B among elderly subjects with laboratory-confirmed influenza. Meta-regression was then applied to explain the sources of heterogeneity. Across 27 estimates identified, the type B detection rate among seniors varied from 5% to 37%. Meta-analysis was not feasible owing to high heterogeneity (I2  = 98.5%). Meta-regression analysis showed that study characteristics, such as number of seasons included, hemisphere, and setting, could have contributed to the heterogeneity observed. The final adjusted model showed that studies that included both outpatients and inpatients reported a significantly (P = .024) lower proportion than those involving outpatients only. The detection rate of type B among the elderly was generally lower than in children/adolescents, but not non-elderly adults. Influenza virus type B has a relatively low detection rate in older adults, especially in settings covering both inpatients and outpatients. Public health implications are discussed.

Clustering of health-related behaviors among early and mid-adolescents in Tuscany: results from a representative cross-sectional study.

Background: A huge amount of literature suggests that adolescents' health-related behaviors tend to occur in clusters, and the understanding of such behavioral clustering may have direct implications for the effective tailoring of health-promotion interventions. Despite the usefulness of analyzing clustering, Italian data on this topic are scant. This study aimed to evaluate the clustering patterns of health-related behaviors. Methods: The present study is based on data from the Health Behaviors in School-aged Children (HBSC) study conducted in Tuscany in 2010, which involved 3291 11-, 13- and 15-year olds. To aggregate students' data on 22 health-related behaviors, factor analysis and subsequent cluster analysis were performed. Results: Factor analysis revealed eight factors, which were dubbed in accordance with their main traits: 'Alcohol drinking', 'Smoking', 'Physical activity', 'Screen time', 'Signs & symptoms', 'Healthy eating', 'Violence' and 'Sweet tooth'. These factors explained 67% of variance and underwent cluster analysis. A six-cluster κ-means solution was established with a 93.8% level of classification validity. The between-cluster differences in both mean age and gender distribution were highly statistically significant. Conclusions: Health-compromising behaviors are common among Tuscan teens and occur in distinct clusters. These results may be used by schools, health-promotion authorities and other stakeholders to design and implement tailored preventive interventions in Tuscany.

One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life.

BACKGROUND: This phase III B follow-up of an initial multicenter study (NCT00226499) will evaluate the ten-year efficacy of two doses of the combined measles-mumps-rubella-varicella vaccine (MMRV) and one dose of the live attenuated varicella vaccine (V) versus a measles-mumps-rubella control group (MMR) for the prevention of clinical varicella disease. Here we present efficacy results for six years post-vaccination. METHODS: In phase A of the study, healthy children aged 12-22 months from ten European countries were randomized (3:3:1) and received either two doses of MMRV, or one dose of combined MMR and one dose of monovalent varicella vaccine (MMR+V), or two doses of the MMR vaccine (control), 42 days apart. Vaccine efficacy against all and against moderate or severe varicella (confirmed by detection of viral DNA or epidemiological link) was assessed from six weeks up to six years post-dose 2 for the MMRV and MMR+V groups, and was calculated with 95% confidence intervals (CI). The severity of varicella was calculated using the modified Vázquez scale (mild ≤ 7; moderately severe = 8-15; severe ≥ 16). Herpes zoster cases were also recorded. RESULTS: 5289 children (MMRV = 2279, mean age = 14.2, standard deviation [SD] = 2.5; MMR+V = 2266, mean age = 14.2, SD = 2.4; MMR = 744, mean age = 14.2, SD = 2.5 months) were included in the efficacy cohort. 815 varicella cases were confirmed. Efficacy of two doses of MMRV against all and against moderate or severe varicella was 95.0% (95% CI: 93.6-96.2) and 99.0% (95% CI: 97.7-99.6), respectively. Efficacy of one dose of varicella vaccine against all and against moderate or severe varicella was 67.0% (95% CI: 61.8-71.4) and 90.3% (95% CI: 86.9-92.8), respectively. There were four confirmed herpes zoster cases (MMR+V = 2, MMR = 2), all were mild and three tested positive for the wild-type virus. CONCLUSIONS: Two doses of the MMRV vaccine and one dose of the varicella vaccine remain efficacious through six years post-vaccination.

A comprehensive analysis of Italian web pages mentioning squalene-based influenza vaccine adjuvants reveals a high prevalence of misinformation.

Squalene-based adjuvants have been included in influenza vaccines since 1997. Despite several advantages of adjuvanted seasonal and pandemic influenza vaccines, laypeople's perception of such formulations may be hesitant or even negative under certain circumstances. Moreover, in Italian, the term "squalene" has the same root as such common words as "shark" (squalo), "squalid" and "squalidness" that tend to have negative connotations. This study aimed to quantitatively and qualitatively analyze a representative sample of Italian web pages mentioning squalene-based adjuvants used in influenza vaccines. Every effort was made to limit the subjectivity of judgments. Eighty-four unique web pages were assessed. A high prevalence (47.6%) of pages with negative or ambiguous attitudes toward squalene-based adjuvants was established. Compared with web pages reporting balanced information on squalene-based adjuvants, those categorized as negative/ambiguous had significantly lower odds of belonging to a professional institution [adjusted odds ratio (aOR) = 0.12, p = .004], and significantly higher odds of containing pictures (aOR = 1.91, p = .034) and being more readable (aOR = 1.34, p = .006). Some differences in wording between positive/neutral and negative/ambiguous web pages were also observed. The most common scientifically unsound claims concerned safety issues and, in particular, claims linking squalene-based adjuvants to the Gulf War Syndrome and autoimmune disorders. Italian users searching the web for information on vaccine adjuvants have a high likelihood of finding unbalanced and misleading material. Information provided by institutional websites should be not only evidence-based but also carefully targeted towards laypeople. Conversely, authors writing for non-institutional websites should avoid sensationalism and provide their readers with more balanced information.

Strategies and actions of multi-purpose health communication on vaccine preventable infectious diseases in order to increase vaccination coverage in the population: The ESCULAPIO project.

The ESCULAPIO Project aims at increasing awareness on vaccine preventable infectious diseases (VPID) and vaccinations in different target populations and to spread the culture of prevention. Information/training interventions on VPID have been developed and health promotion activities for the general population, students and their parents, teachers and health care workers (HCWs) were set up. In Tuscany, educational courses on VPID in high schools were organized and students were stimulated to prepare informative materials on VPID for lower grade school pupils. In Liguria, an educational card game (named 'Vaccine at the Fair') was presented to children of primary schools. Stands in shopping centers were used in Palermo to distribute the regional vaccination schedule and gadgets, also providing indications on reliable websites where to find correct information on vaccinations. A music video played by health care workers (HCWs) was created and used in the University Hospital of Cagliari to promote the anti-flu vaccination campaign in HCWs. In Apulia, meetings with the general population were organized to collect controversial issues about vaccinations and a national call center was launched to create a direct line from the general population to experts in vaccines and vaccination strategies. In Veneto, meetings in the birth centers and home visits for subjects refusing vaccination have been organized. All activities are useful and effective tools to increase knowledge about VPID and confidence in vaccination, which are crucial aspects in order to increase vaccine uptake. The project was funded by the Italian Ministry of Health, Center for Disease Prevention and Control (CCM) in 2013.

The role of age-sex interaction in the development of post-herpetic neuralgia.

Post-herpetic neuralgia is the most frequent complication of herpes zoster and affects up to 30% of patients. Increased age is a well-recognized risk factor, while the role of gender is highly uncertain. Little research has been performed into a possible combined effect of age and sex in post-herpetic neuralgia. The objective of the study was to study the role of age and sex and their combined effect in the development of post-herpetic neuralgia. This retrospective study enrolled adult subjects with at least one episode of herpes zoster in the previous 10 y. A questionnaire on the patient's socio-demographic, anamnestic and clinical characteristics was administered by general practitioners. Multivariable logistic regression was used to detect relationships between post-herpetic neuralgia and age, sex and their interaction. Fifty-nine of 272 patients reported post-herpetic neuralgia: a prevalence of 21.7%. Subjects with post-herpetic neuralgia (mean age 70.9 years) were significantly older (P = .001) than those without (64.2 years), the standardised mean difference being 0.5; no significant between-sex association was revealed (P = .96). A fully adjusted multivariable logistic analysis, however, revealed a highly significant (P = .007) age-sex interaction, with an odds ratio of 0.92; this also showed that older males were more likely to report post-herpetic neuralgia than younger males, while no obvious age-associated pattern was observed among females. We discerned a significant age-by-sex interaction in the development of post-herpetic neuralgia, which suggests that the effect of age on the development of this condition may differ between men and women.

[The economic value of vaccinations: a systematic review of Italian economic evaluations and HTA reports]. / Le implicazioni economiche delle vaccinazioni: una revisione sistematica delle valutazioni economiche e di HTA condotte in Italia.

INTRODUCTION: Decision-making in healthcare should rely on evidence-based approaches able to make possible a transparent and robust assessment of all the aspects related to health technologies. One of the assessment elements is represented by the efficiency that is the specific objective of economic evaluations and also of Health Technology Assessment (HTA). The collection and synthesis of evidence is the first indispensable step in order to foster a proper convey of scientific knowledge to the decision-makers. This work, carried out within a broader project on the transfer of evidence from the scientific to the decision making world, is aimed to release an overview of economic evaluations and HTA on vaccines conducted in Italy. The project was carried out within the activities of the ISPOR Italy-Rome Chapter. METHODS: A systematic review of Italian economic evaluations and HTA performed on vaccines and published up to May 2015 was carried out. PubMed, Scopus and the NIHR HTA databases were queried and a hand-search was performed on key journals in the field (Global & Regional Health Technology Assessment; PharmacoEconomics Italian Research Articles; Giornale italiano di HTA; Politiche Sanitarie; HTA Focus - Pills of Clinical Governance; Pillole di Farmacoeconomia; Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione; IJPH; Quaderni dell'IJPH). Studies were considered eligible if showing the results of a full economic evaluations and if performed in Italy. RESULTS: The literature search yielded 10 HTA reports and 33 economic evaluations. Among the latter, 20 (60,6%) were cost-effectiveness analyses. Ten studies (23,3%) assessed the vaccination against S. pneumoniae figuring out that it is cost-effectiveness and even costsaving in cases of newborns and subjects at risk. Nine studies (20,9%) addressed influenza vaccination and demonstrated its dominance on non-vaccination in the elderly. Eight studies (18,6%) evaluated the HPV vaccines concluding that they are cost-effective. Five studies (11,6%) devoted to anti-rotavirus vaccination showing its dominance on non-vaccination, in particular from the society perspective. Vaccination against pertussis, hepatitis B, chicken pox, measles, rubella, mumps were eventually shown cost-saving. The vaccine against Neisseria meningitidis was considered potentially cost-effective. CONCLUSION: The Italian scientific evidence on efficiency of vaccination is broad and allows concluding that vaccinations are value for money interventions.

Effectiveness of MF59-adjuvanted seasonal influenza vaccine in the elderly: A systematic review and meta-analysis.

BACKGROUND: In the elderly, traditional influenza inactivated vaccines are often only modestly immunogenic, owing to immunosenescence. Given that adjuvantation is a means of enhancing the immune response, the trivalent inactivated vaccine adjuvanted with MF59 (MF59-TIV) was specifically designed to overcome this problem. Considering that, for ethical reasons, the absolute effectiveness of an influenza vaccine in the elderly cannot be demonstrated in placebo-controlled studies, the present study aimed to assess the effectiveness of MF59-TIV in preventing influenza-related outcomes in the elderly. METHODS: We conducted a systematic review of observational studies aimed at evaluating the effectiveness of MF59-TIV against influenza-related outcomes. Results of single studies were pooled whenever possible. RESULTS: Of the 1993 papers screened, 11 (6 case-control, 3 cohort and 2 prospective case-control) studies were identified. Hospitalization due to pneumonia/influenza and laboratory-confirmed influenza were reported in more than one study, while other outcomes (influenza-like illness, cardio- and cerebrovascular accidents) were investigated only by one study each. Pooled analysis of four case-control studies showed an adjusted MF59-TIV effectiveness of 51% (95% CI: 39-61%) against hospitalizations for pneumonia/influenza among community-dwelling seniors. Pooled results of the adjusted vaccine effectiveness against laboratory-confirmed influenza were also high (60.1%), although the 95% CI passed through zero (-1.3 to 84.3%). Other single community-based studies showed very high effectiveness of MF59-TIV in preventing hospitalizations for acute coronary [87% (95% CI: 35-97%)] and cerebrovascular [93% (95% CI: 52-99%)] events. MF59-TIV proved highly effective [94% (95% CI: 47-100%] in reducing influenza-like illness among institutionalized elderly. Furthermore, MF59-TIV displayed greater efficacy than non-adjuvanted vaccines in preventing hospitalizations due to pneumonia/influenza [adjusted risk ratio 0.75 (95% CI: 0.57-0.98)] and laboratory-confirmed influenza [adjusted odds ratio 0.37 (0.14-0.96)]. CONCLUSIONS: Our results suggest that MF59-TIV is effective in reducing several influenza-related outcomes among the elderly, especially hospitalizations due to influenza-related complications.

Economic studies applied to vaccines against invasive diseases: An updated budget impact analysis of age-based pneumococcal vaccination strategies in the elderly in Italy.

Many evaluations have been performed on the economic impact of pneumococcal vaccination in older adults (>64 y of age) in several countries, including Italy. However, these studies did not include the new data on the effectiveness of 13-valent conjugate pneumococcal vaccine (PCV13) in the elderly reported by the CAPiTA Study. The aim of the present study was to update our previous budget impact analysis of multi-cohort PCV13 vaccination in adults in Italy by including new scientific evidence. We also compared single-cohort vaccination strategies per year, in order to identify the cohort with the most favorable economic profile, in the event of the multi-cohort approach not being economically sustainable for the National Health System (NHS). The new impact analysis highlights that the vaccination of one, two or three adult cohorts per year in Italy would lead to a considerable reduction in pneumococcal disease and its related costs over 5 y. The strategies proved cost-effective (ICERs ranging from €14,605 to €15,412/QALY), i.e. well below the threshold of €50,000/QALY. The ICERs were slightly lower than those calculated in the first published analysis and vaccination continued to be economically favorable. In the case of a mono-cohort strategy, the vaccination of 65-year-old subjects, albeit more expensive, proved to be more favorable than the vaccination of 70- or 75-year-old cohorts. Finally, after the inclusion of the recent clinical evidence, the age-based PCV13 vaccination of the elderly in Italy continued to be economically justified from the NHS perspective in the short period. Vaccination of the elderly should therefore be strongly recommended nationwide in Italy.

Assessing spatial inequalities in accessing community pharmacies: a mixed geographically weighted approach.

Geographical accessibility is an important determinant for the utilisation of community pharmacies. The present study explored patterns of spatial accessibility with respect to pharmacies in Liguria, Italy, a region with particular geographical and demographic features. Municipal density of pharmacies was proxied as the number of pharmacies per capita and per km2, and spatial autocorrelation analysis was performed to identify spatial clusters. Both non-spatial and spatial models were constructed to predict the study outcome. Spatial autocorrelation analysis showed a highly significant clustered pattern in the density of pharmacies per capita (I=0.082) and per km2 (I=0.295). Potentially under-supplied areas were mostly located in the mountainous hinterland. Ordinary least-squares (OLS) regressions established a significant positive relationship between the density of pharmacies and income among municipalities located at high altitudes, while no such association was observed in lower-lying areas. However, residuals of the OLS models were spatially auto-correlated. The best-fitting mixed geographically weighted regression (GWR) models outperformed the corresponding OLS models. Pharmacies per capita were best predicted by two local predictors (altitude and proportion of immigrants) and two global ones (proportion of elderly residents and income), while the local terms population, mean altitude and rural status and the global term income functioned as independent variables predicting pharmacies per km2. The density of pharmacies in Liguria was found to be associated with both socio-economic and landscape factors. Mapping of mixed GWR results would be helpful to policy-makers.

An eHealth Project on Invasive Pneumococcal Disease: Comprehensive Evaluation of a Promotional Campaign.

BACKGROUND: The recently launched Pneumo Rischio eHealth project, which consists of an app, a website, and social networking activity, is aimed at increasing public awareness of invasive pneumococcal disease (IPD). The launch of this project was prompted by the inadequate awareness of IPD among both laypeople and health care workers, the heavy socioeconomic burden of IPD, and the far from optimal vaccination coverage in Italy, despite the availability of safe and effective vaccines. OBJECTIVE: The objectives of our study were to analyze trends in Pneumo Rischio usage before and after a promotional campaign, to characterize its end users, and to assess its user-rated quality. METHODS: At 7 months after launching Pneumo Rischio, we established a 4-month marketing campaign to promote the project. This intervention used various approaches and channels, including both traditional and digital marketing strategies. To highlight usage trends, we used different techniques of time series analysis and modeling, including a modified Mann-Kendall test, change-point detection, and segmented negative binomial regression of interrupted time series. Users were characterized in terms of demographics and IPD risk categories. Customer-rated quality was evaluated by means of a standardized tool in a sample of app users. RESULTS: Over 1 year, the app was accessed by 9295 users and the website was accessed by 143,993 users, while the project's Facebook page had 1216 fans. The promotional intervention was highly effective in increasing the daily number of users. In particular, the Mann-Kendall trend test revealed a significant (P ≤.01) increasing trend in both app and website users, while change-point detection analysis showed that the first significant change corresponded to the start of the promotional campaign. Regression analysis showed a significant immediate effect of the intervention, with a mean increase in daily numbers of users of 1562% (95% CI 456%-4870%) for the app and 620% (95% CI 176%-1777%) for the website. Similarly, the postintervention daily trend in the number of users was positive, with a relative increase of 0.9% (95% CI 0.0%-1.8%) for the app and 1.4% (95% CI 0.7%-2.1%) for the website. Demographics differed between app and website users and Facebook fans. A total of 69.15% (10,793/15,608) of users could be defined as being at risk of IPD, while 4729 users expressed intentions to ask their doctor for further information on IPD. The mean app quality score assigned by end users was approximately 79.5% (397/500). CONCLUSIONS: Despite its specific topic, Pneumo Rischio was accessed by a considerable number of users, who ranked it as a high-quality project. In order to reach their target populations, however, such projects should be promoted.

Development and validation of the Italian version of the Mobile Application Rating Scale and its generalisability to apps targeting primary prevention.

BACKGROUND: A growing body of literature affirms the usefulness of mobile technologies, including mobile applications (apps), in the primary prevention field. The quality of health apps, which today number in the thousands, is a crucial parameter, as it may affect health-related decision-making and outcomes among app end-users. The mobile application rating scale (MARS) has recently been developed to evaluate the quality of such apps, and has shown good psychometric properties. Since there is no standardised tool for assessing the apps available in Italian app stores, the present study developed and validated an Italian version of MARS in apps targeting primary prevention. METHODS: The original 23-item version of the MARS assesses mobile app quality in four objective quality dimensions (engagement, functionality, aesthetics, information) and one subjective dimension. Validation of this tool involved several steps; the universalist approach to achieving equivalence was adopted. Following two backward translations, a reconciled Italian version of MARS was produced and compared with the original scale. On the basis of sample size estimation, 48 apps from three major app stores were downloaded; the first 5 were used for piloting, while the remaining 43 were used in the main study in order to assess the psychometric properties of the scale. The apps were assessed by two raters, each working independently. The psychometric properties of the final version of the scale was assessed including the inter-rater reliability, internal consistency, convergent, divergent and concurrent validities. RESULTS: The intralingual equivalence of the Italian version of the MARS was confirmed by the authors of the original scale. A total of 43 apps targeting primary prevention were tested. The MARS displayed acceptable psychometric properties. The MARS total score showed an excellent level of both inter-rater agreement (intra-class correlation coefficient of .96) and internal consistency (Cronbach's α of .90 and .91 for the two raters, respectively). Other types of validity, including convergent, divergent, discriminative, known-groups and scalability, were also established. CONCLUSIONS: The Italian version of MARS is a valid and reliable tool for assessing the health-related primary prevention apps available in Italian app stores.

Fluzone® intra-dermal (Intanza®/Istivac® Intra-dermal): An updated overview.

Influenza is a highly contagious respiratory acute viral disease which imposes a very heavy burden both in terms of epidemiology and costs, in the developed countries as well as in the developing ones. It represents a serious public health concern and vaccination constitutes an important tool to reduce or at least mitigate its burden. Despite the existence of a broad armamentarium against influenza and despite all the efforts and recommendations of international organisms to broaden immunization, influenza vaccination coverage is still far from being optimal. This, taken together with logistic and technical difficulties that can result into vaccine shortage, makes intra-dermal (ID) vaccines, such as Fluzone® ID and Intanza®, particularly attractive. ID vaccines are comparable and, in some cases, superior to intra-muscular/sub-cutaneous vaccines in terms of immunogenicity, safety, reactogenicity, tolerability and cross-protection profiles, as well as in terms of patient preference, acceptance and vaccine selection. Further advances, such as Fluzone® ID with alternative B strains and Quadrivalent Fluzone® ID or the possibility of self-administering the vaccines, make influenza ID vaccines even more valuable.

Vaccinating Italian infants with a new multicomponent vaccine (Bexsero®) against meningococcal B disease: A cost-effectiveness analysis.

The European Medicines Agency has approved a multicomponent serogroup B meningococcal vaccine (Bexsero®) for use in individuals of 2 months of age and older. A cost-effectiveness analysis (CEA) from the societal and Italian National Health Service perspectives was performed in order to evaluate the impact of vaccinating Italian infants less than 1 y of age with Bexsero®, as opposed to non-vaccination. The analysis was carried out by means of Excel Version 2011 and the TreeAge Pro® software Version 2012. Two basal scenarios that differed in terms of disease incidence (official and estimated data to correct for underreporting) were considered. In the basal scenarios, we considered a primary vaccination cycle with 4 doses (at 2, 4, 6 and 12 months of age) and 1 booster dose at the age of 11 y, the societal perspective and no cost for death. Sensitivity analyses were carried out in which crucial variables were changed over probable ranges. In Italy, on the basis of official data on disease incidence, vaccination with Bexsero® could prevent 82.97 cases and 5.61 deaths in each birth cohort, while these figures proved to be three times higher on considering the estimated incidence. The results of the CEA showed that the Incremental Cost Effectiveness Ratio (ICER) per QALY was €109,762 in the basal scenario if official data on disease incidence are considered and €26,599 if estimated data are considered. The tornado diagram indicated that the most influential factor on ICER was the incidence of disease. The probability of sequelae, the cost of the vaccine and vaccine effectiveness also had an impact. Our results suggest that vaccinating infants in Italy with Bexsero® has the ability to significantly reduce meningococcal disease and, if the probable underestimation of disease incidence is considered, routine vaccination is advisable.

Development and preliminary data on the use of a mobile app specifically designed to increase community awareness of invasive pneumococcal disease and its prevention.

Given the growing use and great potential of mobile apps, this project aimed to develop and implement a user-friendly app to increase laypeople's knowledge and awareness of invasive pneumococcal disease (IPD). Despite the heavy burden of IPD, the documented low awareness of IPD among both laypeople and healthcare professionals and far from optimal pneumococcal vaccination coverage, no app specifically targeting IPD has been developed so far. The app was designed to be maximally functional and conceived in accordance with user-centered design. Its content, layout and usability were discussed and formally tested during several workshops that involved the principal stakeholders, including experts in IPD and information technology and potential end-users. Following several workshops, it was decided that, in order to make the app more interactive, its core should be a personal "checker" of the risk of contracting IPD and a user-friendly risk-communication strategy. The checker was populated with risk factors identified through both Italian and international official guidelines. Formal evaluation of the app revealed its good readability and usability properties. A sister web site with the same content was created to achieve higher population exposure. Seven months after being launched in a price- and registration-free modality, the app, named "Pneumo Rischio," averaged 20.9 new users/day and 1.3 sessions/user. The first in-field results suggest that "Pneumo Rischio" is a promising tool for increasing the population's awareness of IPD and its prevention through a user-friendly risk checker.

Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine and Commonly Administered Vaccines After Coadministration.

BACKGROUND: Given the broad age range across which the quadrivalent meningococcal conjugate vaccine MenACWY-CRM is used, coadministration with routine vaccines should be evaluated across age groups for possible immunologic interference and impact on vaccine reactogenicity and safety. METHODS: We summarize data from a large population of infants, adolescents and international travelers from 10 phase 3 or 4 clinical studies to evaluate coadministration of MenACWY-CRM with commonly administered vaccines. Noninferiority analyses of immune responses were performed across studies and age groups for each vaccine. Reactogenicity and safety were also assessed. RESULTS: In infants, MenACWY-CRM coadministered with routine vaccines did not reduce immune responses to diphtheria, tetanus, poliovirus, hepatitis B, Haemophilus influenzae type b, pneumococcal conjugate, measles-mumps-rubella, varicella or pertussis antigens. Noninferiority criteria were not met for some pneumococcal conjugate serotypes at 7 months of age, but no consistent trends were observed. In adolescents, coadministration did not reduce immune responses to tetanus, diphtheria and human papilloma virus vaccine antigens. Noninferiority criteria for pertussis antigens were not uniformly met in infant and adolescent studies, although the clinical relevance is unclear. In adults, coadministration did not reduce immune responses to hepatitis A/B, typhoid fever, yellow fever, Japanese encephalitis and rabies antigens. Immune responses to MenACWY-CRM were not impacted by coadministration of commonly administered vaccines. Coadministration did not increase frequencies of postvaccination adverse events in any age group. CONCLUSIONS: With no clinically relevant vaccine interactions or impact on vaccine reactogenicity or safety, these results support the coadministration of MenACWY-CRM with routine vaccines in all age groups.

Assessing Ebola-related web search behaviour: insights and implications from an analytical study of Google Trends-based query volumes.

BACKGROUND: The 2014 Ebola epidemic in West Africa has attracted public interest worldwide, leading to millions of Ebola-related Internet searches being performed during the period of the epidemic. This study aimed to evaluate and interpret Google search queries for terms related to the Ebola outbreak both at the global level and in all countries where primary cases of Ebola occurred. The study also endeavoured to look at the correlation between the number of overall and weekly web searches and the number of overall and weekly new cases of Ebola. METHODS: Google Trends (GT) was used to explore Internet activity related to Ebola. The study period was from 29 December 2013 to 14 June 2015. Pearson's correlation was performed to correlate Ebola-related relative search volumes (RSVs) with the number of weekly and overall Ebola cases. Multivariate regression was performed using Ebola-related RSV as a dependent variable, and the overall number of Ebola cases and the Human Development Index were used as predictor variables. RESULTS: The greatest RSV was registered in the three West African countries mainly affected by the Ebola epidemic. The queries varied in the different countries. Both quantitative and qualitative differences between the affected African countries and other Western countries with primary cases were noted, in relation to the different flux volumes and different time courses. In the affected African countries, web query search volumes were mostly concentrated in the capital areas. However, in Western countries, web queries were uniformly distributed over the national territory. In terms of the three countries mainly affected by the Ebola epidemic, the correlation between the number of new weekly cases of Ebola and the weekly GT index varied from weak to moderate. The correlation between the number of Ebola cases registered in all countries during the study period and the GT index was very high. CONCLUSION: Google Trends showed a coarse-grained nature, strongly correlating with global epidemiological data, but was weaker at country level, as it was prone to distortions induced by unbalanced media coverage and the digital divide. Global and local health agencies could usefully exploit GT data to identify disease-related information needs and plan proper communication strategies, particularly in the case of health-threatening events.