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Background: We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia., Methods: This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12-22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirmed by viral DNA detection or epidemiological link and clinical assessment) was calculated with 95% confidence intervals using Cox proportional hazards regression model. Immunogenicity was assessed as seropositivity rates and geometric mean concentrations (GMCs). Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded., Results: A total of 3705 children were vaccinated (1590, MMRV group; 1586, MMR + V group; 529, MMR group). There were 663 confirmed varicella cases (47, MMRV group; 349, MMR + V group; 267, MMR group). VE ranged between 95.4% (Lithuania) and 97.4% (Slovakia) in the MMRV group and between 59.3% (Lithuania) and 74% (Slovakia) in the MMR + V group. At year 10, seropositivity rates were 99.5%-100% in the MMRV group, 98%-100% in the MMR + V group and 50%-100% in the MMR control group, and the anti-VZV antibody GMCs were comparable between MMRV and MMR + V groups. The occurrence of solicited and unsolicited AEs was similar across groups and no SAE was considered as vaccination-related. No new safety concerns were identified., Conclusions: Our results indicated that two doses of varicella zoster virus-containing vaccine provided better protection than one dose against varicella and induced antibody responses that persisted 10 years post-vaccination., Competing Interests: Declaration of Competing Interest GC, MAH, MP are employees of the GSK group of companies, and GC and MAH hold shares in the GSK group of companies as part of the employee remuneration. DV, JW, MS, RP, VU have received grants from the GSK group of companies during the conduct of the study. JW, MS have received consulting and lecture fees from the GSK group of companies. MS has received non-financial support from the GSK group of companies to attend scientific meetings, outside the submitted work. DV reports to have received personal fees by Biovomed during the conduct of the study. DV moreover reports to have received personal fees from the GSK group of companies, MSD, Sanofi and Pfizer, outside the submitted work. RR reports that her institution received fees during the conduct of the study. DP, GL, HCa, HCz, JB, NM, PP, RC, SM have not received any consulting fees and declare that they have no conflicts of interest and have no non-financial interest to declare., (Copyright © 2021 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd.. All rights reserved.)

Background: The beginning of the coronavirus disease (COVID-19) epidemic dates back to December 31, 2019, when the first cases were reported in the People's Republic of China. In the Czech Republic, the first three cases of infection with the novel coronavirus were confirmed on March 1, 2020. The joint effort of state authorities and researchers gave rise to a unique team, which combines methodical knowledge of real-world processes with the know-how needed for effective processing, analysis, and online visualization of data., Objective: Due to an urgent need for a tool that presents important reports based on valid data sources, a team of government experts and researchers focused on the design and development of a web app intended to provide a regularly updated overview of COVID-19 epidemiology in the Czech Republic to the general population., Methods: The cross-industry standard process for data mining model was chosen for the complex solution of analytical processing and visualization of data that provides validated information on the COVID-19 epidemic across the Czech Republic. Great emphasis was put on the understanding and a correct implementation of all six steps (business understanding, data understanding, data preparation, modelling, evaluation, and deployment) needed in the process, including the infrastructure of a nationwide information system; the methodological setting of communication channels between all involved stakeholders; and data collection, processing, analysis, validation, and visualization., Results: The web-based overview of the current spread of COVID-19 in the Czech Republic has been developed as an online platform providing a set of outputs in the form of tables, graphs, and maps intended for the general public. On March 12, 2020, the first version of the web portal, containing fourteen overviews divided into five topical sections, was released. The web portal's primary objective is to publish a well-arranged visualization and clear explanation of basic information consisting of the overall numbers of performed tests, confirmed cases of COVID-19, COVID-19-related deaths, the daily and cumulative overviews of people with a positive COVID-19 case, performed tests, location and country of infection of people with a positive COVID-19 case, hospitalizations of patients with COVID-19, and distribution of personal protective equipment., Conclusions: The online interactive overview of the current spread of COVID-19 in the Czech Republic was launched on March 11, 2020, and has immediately become the primary communication channel employed by the health care sector to present the current situation regarding the COVID-19 epidemic. This complex reporting of the COVID-19 epidemic in the Czech Republic also shows an effective way to interconnect knowledge held by various specialists, such as regional and national methodology experts (who report positive cases of the disease on a daily basis), with knowledge held by developers of central registries, analysts, developers of web apps, and leaders in the health care sector., (©Martin Komenda, Vojtěch Bulhart, Matěj Karolyi, Jiří Jarkovský, Jan Mužík, Ondřej Májek, Lenka Šnajdrová, Petra Růžičková, Jarmila Rážová, Roman Prymula, Barbora Macková, Pavel Březovský, Jan Marounek, Vladimír Černý, Ladislav Dušek. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 27.05.2020.)

To support a fully liquid, diphtheria (D)-tetanus (T)-acellular pertussis (aP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) vaccine in Europe using a 2, 3, 4 month primary series and a booster at 11-15 months of age. Phase III, randomized, observer-blind studies in Germany and the Czech Republic. Participants who had not received HB vaccine were randomized to a 2, 3, 4 month primary series of DTaP-IPV-HB-PRP-T (group 1; N = 266) or a reconstituted DTaP-HB-IPV//PRP-T comparator (group 2; N = 263) and a booster of the same vaccine. Pneumococcal vaccine (PCV13) and rotavirus vaccine were coadministered at 2, 3, 4 months, and the booster was coadministered with PCV13. Noninferiority (group 1 versus group 2) was tested postprimary series for seroprotection rates (anti-HB and anti-PRP) and vaccine response rates (anti-pertussis toxin and anti-filamentous hemagglutinin). Safety was assessed by parental reports. Noninferiority was demonstrated with the lower bound of the 95% confidence interval for the difference (group 1 to group 2) being > -10% for each comparison. Primary series immune responses were high for all antigens and similar in each group. Prebooster antibody persistence was good, and there was a strong anamnestic response, both being similar for the investigational and control vaccines. Responses to PCV13 and rotavirus vaccine were similar in each group. There were no safety concerns. These data support the use of the DTaP-IPV-HB-PRP-T vaccine in a 2, 3, 4 month schedule without a birth dose of HB vaccine, with a booster dose in the second year of life administered with routine childhood vaccines.

Background: To provide broader protection against pneumococcal disease, new vaccines containing conserved Streptococcus pneumoniae proteins are being developed. This study assessed the safety, reactogenicity and immunogenicity of four formulations containing pneumococcal proteins pneumolysin toxoid (dPly) and histidine triad protein (PhtD) in toddlers., Methods: In this phase II, multicenter, observer-blind study (www.clinicaltrials.gov: NCT00985751) conducted in the Czech Republic, toddlers (12-23 months) were randomized (1:1:1:1:1) to receive one of four investigational vaccine formulations (10 or 30μg each of dPly and PhtD, alone or in combination with polysaccharide conjugates from the pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine [PHiD-CV]), or the licensed PHiD-CV, in a 2-dose primary series plus booster at study months 0, 2 and 6. Solicited local and general symptoms were recorded within seven days post-vaccination, unsolicited symptoms within 31 days post-vaccination, and serious adverse events (SAEs) during the entire study period. Antibody concentrations against the vaccine components were measured pre-vaccination, one month post-dose 2, pre- and one month post-booster., Results: 257 toddlers were enrolled and vaccinated. Percentages of solicited local and general symptoms following the different investigational formulations were generally within the same ranges as for PHiD-CV. After each dose, grade 3 fever (>40.0°C, rectal measurement) was reported for maximum one toddler in each group with no differences between investigational formulations and PHiD-CV during primary vaccination. 23 SAEs were reported for 17 toddlers, with distribution balanced between all groups except the group receiving 30 μg dPly/PhtD with PHiD-CV-conjugates (no SAEs reported). None of the SAEs were considered to be vaccine-related. For all pneumococcal protein-containing formulations, anti-PhtD and anti-Ply antibody geometric mean concentrations increased from pre-vaccination to post-dose 2 and from pre- to post-booster vaccination., Conclusion: All investigational vaccine formulations were well-tolerated and immunogenic when administered to toddlers as a 2-dose primary vaccination followed by a booster dose., (Copyright © 2014. Published by Elsevier Ltd.)

Coinfection by HIV and syphilis has become a growing problem due to the re-appearance of unsafe sexual practices in the era of potent anti-retroviral drugs. We describe a repeated import of syphilis by a couple of men-who-have-sex-with-men from Thailand to Czech Republic likely due to non-adherence of the patients to physician recommendations. Such cases can become foci for dissemination of once locally rare infections and present a danger for the community., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

We estimate and describe the incidence rates, mortality, and cost of CAP (community-acquired pneumonia), in both inpatient and outpatient settings, in the Czech Republic (CZ), Slovakia (SK), Poland (PL), and Hungary (HU). A retrospective analysis was conducted on administrative data from the health ministry and insurance reimbursement claims with a primary diagnosis of pneumonia in 2009 to determine hospitalization rates, costs, and mortality in adults ≥50 years of age. Patient chart reviews were conducted to estimate the number of outpatient cases. Among all adults ≥50 years, the incidence of hospitalized CAP per 100,000 person years was: 456.6 (CZ), 504.6 (SK), 363.9 (PL), and 845.3 (HU). The average fatality rate for all adults ≥50 is 19.1%, and for each country; 21.7% (CZ), 20.9% (SK), 18.6% (PL), 17.8% (HU). Incidence, fatality, and likelihood of hospitalization increased with advancing age. Total healthcare costs of CAP in EUR was 12,579,543 (CZ); 9,160,774 (SK); 22,409,085 (PL); and 18,298,449 (HU); with hospitalization representing over 90% of the direct costs of treatment. The burden of CAP increases with advancing age in four CEE countries, with hospitalizations driving the costs of CAP upwards in the elderly population. Mortality rates are generally higher than reported in Western EU countries.

Introduction: Intanza(®)/IDflu(®) (Sanofi Pasteur SA, Lyon, France), a split-virion, trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available in adults 18-59 years of age (9 μg) and ≥60 years of age (15 μg) as of the 2010/2011 northern hemisphere influenza season., Methods: This study assessed the acceptability of intradermal vaccination with Intanza/IDflu in routine clinical practice in adult vaccinees and their vaccine prescribers. Vaccine prescribers and adults who had elected to be vaccinated with Intanza/IDflu during the 2010/2011 northern hemisphere influenza season were recruited to complete surveys about their opinions of influenza vaccination and their acceptance of the intradermal vaccination. Czech subjects 18-59 years of age were vaccinated with the 9 μg formulation and those ≥60 years of age with the 15 μg formulation of Intanza/IDflu. All Turkish subjects were vaccinated with the 9 μg formulation, as Intanza/IDflu 15 μg was not available in Turkey at the time the survey was conducted., Results: One thousand and twelve vaccinees and 28 vaccine prescribers in the Czech Republic, and 249 vaccinees and 15 vaccine prescribers in Turkey completed questionnaires. Overall, 96.1% of vaccinees were satisfied or very satisfied with Intanza/IDflu. The main reason for satisfaction was that the injection was considered minimally painful. Most (93.9%) vaccinees reported that they would prefer to receive the same vaccination next year. Furthermore, 95.3% of vaccine prescribers were satisfied or very satisfied with the intradermal vaccine, and 82.6% preferred intradermal over intramuscular vaccination., Conclusions: Intradermal vaccination for seasonal influenza using Intanza/IDflu is well accepted by adult vaccinees and vaccine prescribers. By providing an additional, well-accepted method, Intanza/IDflu might help increase seasonal influenza vaccination rates in adults.

Pertussis epidemiology was examined in selected Central and Eastern European countries andTurkey (CEEs) from 1945 to 2005. Epidemiology and immunisation coverage data were collected fromNational Health Departments and Epidemiology Institutes. Pertussis diagnosis was made by the World Health Organization (WHO) clinical criteria, laboratory confirmation and/or epidemiological link, except for Romania (WHO clinical case definition used). In the pre-vaccine era, pertussis incidence (except Turkey) exceeded 200/100,000 (range180-651/100,000), with 60-70% of cases occurring in pre-school children. Until 2007, a second-year booster was givenin Estonia, Lithuania and Turkey, and an additional pre-school booster elsewhere. During 1995-2005, immunisation coverage by the age of 2 years exceeded 80% (range 80-98%) and, excluding Estonia, pertussis incidence was <3/100,000. Age-specific incidence rates rose in 5-14 year olds in Poland, Estonia and the Czech Republic. Incidence rates in children <1 year of age remained unchanged. There were two age distribution patterns. In the Czech Republic and Estonia, 16% of cases occurred in pre-school children and 17% and 22% in children >15 years of age, respectively; in Romania, Turkey and Lithuania, 51%, 71% and 73%, respectively, occurred in pre-school children and <7% in children aged >15 years.Pertussis infection persists, despite high immunisation coverage. Compared with the pre-vaccine era, the age distribution changed differentially in CEEs, with an apparent shift towards older children.

Study Objective: To determine prevalence rates of antibodies against hepatitis A virus (HAV) and hepatitis B virus (HBV) in the general adult male and female population over 40 years of age with no history of viral hepatitis A (VHA) and viral hepatitis B (VHB) who have never been vaccinated against hepatitis and to assess the cost-effectiveness of the pre-vaccination serological screening., Material and Methods: In 2003-2004, a total of 972 persons of three age categories: 41-50 years, 51-60 years, 61 and more years, were screened. Persons with a history of VHA and/or VHB and those who had been vaccinated against hepatitis were not included in the study. The following four indicators were determined from a 5 ml specimen of whole venous blood by electrochemiluminiscence assay: total anti-HAV antibodies, total anti-HBc antibodies, anti-HBs antibodies and HBsAg, as the most suitable markers of experienced hepatitis or previous vaccination., Results: The prevalence rates of anti-HAV antibodies were lower in females compared to males for all of the three age categories. These antibodies were detected in 16.8%, 52.9% and 77.5% of 41-50-year-olds, 51-60-year-olds and > or = 61-year-olds, respectively. The total prevalence rate for the three age groups was 61.6%. The anti-HBc antibody seroprevalence rates were 1.9%, 5.3% and 6.1%, respectively., Conclusion: The results show high prevalence of VHA in higher age groups. Such a high seroprevalence of antibodies in nonvaccinated persons with no history of viral hepatitis is suggestive of a very frequent incidence of asymptomatic infection. For this reason, the prevaccination screening of anti-HAV antibodies is cost-effective in the population over 50 years of age but is not justified in persons under 40 years of age. Prevaccination screening for anti-HBc antibodies appears not to be cost-effective regardless of age in view of their low prevalence in the Czech population.

Background & Objectives: The availability of a type-specific pneumococcal vaccine for children is a worldwide problem. It is necessary to study the serotypes prevalent in a country before introducing a type-specific vaccine. The objective of the present study was to analyse the prevalence of Streptococcus pneumoniae serotypes in children suffering from acute otitis media or invasive pneumococcal disease and to compare a coverage of serotypes by individual pneumococcal vaccines., Methods: Children suffering from acute otitis media and invasive pneumococcal disease were analysed in the Czech Republic from October 1999 to November 2000. Serotyping was performed by the quellung technique using antisera from Statens Serum Institute (Denmark)., Results: The most frequent serotypes in patients with acute otitis media were 3, 19F, 23F, 14, 9V, 1, 6B, 11A and 28F. Vaccine coverage for the identified serotypes in acute otitis media patients was 52.1 per cent for the 7-valent vaccine, 57.8 per cent for the 9-valent vaccine and 75.7 per cent for the 11-valent form of the vaccine. In 108 patients with invasive pneumococcal disease, the most frequent serotypes were 6B, 9V, 14, 19F, 3 and 23F. Vaccine coverage for the identified serotypes in patients with invasive pneumococcal disease was 62 per cent for the 7-valent vaccine, 66.4 per cent for the 9-valent vaccine and 77.5 per cent for the 11-valent form of the vaccine., Interpretation & Conclusion: Vaccine coverage for the identified serotypes for the 11-valent pneumococcal vaccine was better than the other two vaccines.

Influenza is a very serious disease, which causes thousands of deaths all over the world every year. As there is so far no sufficiently effective causal therapy of influenza the main function of vaccination lies in prevention. Influenza is a major problem especially in collective facilities. Therefore, great emphasis is laid in the Czech Republic Army on the vaccination of military groups and on the evaluation of reactogenicity and immunogenicity of the vaccines used. The specific aim of the clinical trial was to evaluate the reactogenicity and immunogenicity of two inactivated split influenza vaccines Fluarix and Vaxigrip in healthy adult volunteers aged 18-60 years with stress on military groups. The study was designed as an open clinical trial with 2 groups each of 100 volunteers in one centre. Randomisation was not conducted so that each group received only the vaccine specified beforehand. Both the inactivated split vaccines evaluated, Vaxigrip and Fluarix are highly immunogenic both against declared and other antigenic variants of influenza. The study has demonstrated a favourable trend in the preparation of influenza vaccines towards a marked reduction of general solicited symptoms as compared with previous years. Despite minute differences in immunogenicity and reactogenicity, the vaccines are generally speaking comparable, and in healthy individuals aged 18-60 years they induce a sufficient protection against the onset and development of influenza. The results of our open clinical trial (without randomisation) have again proved that both manufacturers produce vaccines of a high European standard.

Viral hepatitis A is a common disease, particularly in developing countries. All staff and troops of the U.N. (United Nations) are vaccinated by the Havrix vaccine. Till 1995 we did not vaccinate Czech troops which have operated in the area of former Yugoslavia. The main goal of this study was to obtain data about the seroprevalence of hepatitis A antibody among the Czech U.N. troops before their departure to the conflict area and to optimize the vaccination approach. The serum samples were examined by the MEIA (Microparticle Enzyme Immunoassay) method in the fully automated system for immunoassays IMx in the Military Institute of Health in Ceské Budĕjovice. We used HAVAB kits of Abbott Company. 692 serum samples (military staff of the Czech U.N. troops in Yugoslavia) were examined in 1991-1995. In the laboratory 19 samples were eliminated due to small amounts (less than 50 microliters) or haemolysis. 673 (1991 - 65, 1992 - 296, 1993 - 265, 1994 - 35, 1995 - 12) were investigated. The staff was divided into four age cohorts by decades (20-29, 30-39, 40-49, 50-59); 26.0%, 47.4%, 24.9% and 1.7%, respectively. There were 253 (37.4%) positive samples and 420 (62.6%) negatives ones, ratio 1:1.7. The ratio of the positive and negative samples--immunity rate and seroprevalence--were 1:0.4 (26.2%), 1:0.6 (37.9%); 1:0.9 (46.4%) and 1:2.7 (72.7%), respectively in the age cohorts. The results show a relatively low seroprevalence of the anti-HAV antibody in all the age cohorts and necessity to vaccinate the Czech U.N. troops by the special basic schedule--Havrix 2 x 720 E.U. at the same time. This regimen will be used in the new units that will be stationed in Bosnia. So far 200 persons have been vaccinated in this way.

Viral hepatitis A is a common disease particularly in developing countries. That disease is endemic and it is always associated with poor standards of sanitation. All staff and troops in the U.N. (United Nations) are vaccinated by the Havrix vaccine. Till 1995 we did not vaccinate the Czech troops which have operated in the area of the former Yugoslavia. The main goal of this study was to obtain data about the seroprevalence of hepatitis A antibody among the Czech U.N. troops before their departure to the conflict area. The serum samples were investigated by the MEIA (Microparticle Enzyme Immunoassay) method in the fully automated system for immunoassays IMx in the Military Institute of Health in Ceské Budĕjovice. We use the HAVAB investigation kits of the Abbott company. We obtained 884 serum samples (military staff of the Czech U.N. troops in Yugoslavia) in the years 1991-1995. In the laboratory we excluded 19 of the samples due to the small amount (less than 50 ul) or hemolysis. We investigated 865 of them (1991--65, 1992--296, 1993--265, 1994--35, 1995--204). The staff was divided into four age cohorts by ten years (20-29, 30-39, 40-49, 50-59), where the distribution of percentage was 32.6%, 43.6%, 22.5%, and 1.3% respectively. The positive samples were 287 (average seroprevalence was 33.2%, CI 30.1%-36.3%), the negative ones were 578 (66.8%). The seroprevalence 18.1% (CI 13.6%-22.6%), 36.1% (CI 31.3%-40.9%), 47.1% (CI 40.1%-54.1%), 72.7% (CI 46.4%-99.0%) in the age cohorts. The results show relatively low seroprevalence of the anti-HAV antibody in all the age cohorts and necessity to vaccinate the Czech UNPROFOR or IFOR units by Havrix before their departure to conflict area.

Viral hepatitis A is a frequent disease particularly in developing countries. All workers and UN forces (UNO) are vaccinated against VHA with Havrix vaccine. The Czech units which were and are engaged on the territory of former Jugoslavia are not yet vaccinated against this contagious disease. The main purpose of the present study was to assess the immunity rate of VHA among Czech soldiers of the UN forces before their departure to the site of action. Another objective was to assess a suitable vaccination procedure. Sera were examined by the MEIA method (Microparticle Enzyme Immunoassay) in a fully automated IMx system in the Military Health Institute, Ceské Budĕjovice. For investigation HAVAB kits of Abbott Co. were used. A total of 667 serum samples were assembled, 19 had to be discarded because of small amounts (less than 50 microliters or because of haemolysis. The positive titre of "total" antibodies was set at 35 mIU anti-HAV; thus a total of 648 specimens were examined in 1991 - 1994 (1991 - 65, 1992 - 296, 1993 - 265, 1994 - 22). Of these 249 (38.4%) were positive and 399 (61.6%) were negative. The examined subjects were divided into four age groups (20 - 29, 30 - 39, 40 - 49, 50 - 59), the approximate distribution being 23%, 50%, 25%, 2%. The ratio of negative and positive specimens in different age groups was 1:0.3, 1:0.6, 1:1, 1:2.7. The seroprevalence of anti-HAV antibody increases from 25.3% in the first age group, in the second one it is 37.9%, in the third one 49.5% and 72.7% in the last age group, i.e. in the age bracket of 50 - 59 years. The results indicate a very low immunity rate in the lower age brackets and the necessity to vaccinate them before they depart. It is beyond doubt that it pays to examine the soldiers for the presence of total anti-HAV and immunize only subjects with a negative antibody titre. The vaccination approach Havrix 2 x 720 EU was recommended.

Viral hepatitis is a serious medical and economic problem. By far the most frequent viral hepatitis occurring in Czechoslovak army is viral hepatitis A. Although the trends of the global incidence of hepatitis A in the Czech Army are identical with the trends in the civilian sector and thus descending, the great danger for the military sector arises specially from specific conditions of organized life. Screening and postexposure gammaglobulin prophylaxis with 70% protection are proved most effective. The protection is lower than the values published by authors abroad, but this is connected with the time of gammaglobulin administration. Norga prophylaxis is quite justified, in indicated cases, i.e. in contacts and in time.