Immune Responses to Booster Vaccination With Meningococcal ABCWY Vaccine After Primary Vaccination With Either Investigational or Licensed Vaccines: A Phase 2 Randomized Study.

Background: Current meningococcal prime-boost vaccination schedules include separate vaccines for serogroups ACWY and B. An investigational combined serogroups ABCWY vaccine (MenABCWY) was developed to protect against clinically important Neisseria meningitidis serogroups.

Methods: In this phase 2, randomized, observer-blind, extension study (NCT01272180), participants 10-25 years of age received 1 booster dose of MenABCWY vaccine at 24 months (M) postprimary series of MenABCWY (2 doses), 4CMenB (2 doses) or MenACWY-CRM vaccine (1 dose).

A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations.

Objective: Prophylactic antipyretic use during pediatric vaccination is common. This study assessed whether paracetamol or ibuprofen prophylaxis interfere with immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13) given concomitantly with the combined DTaP/HBV/IPV/Hib vaccine.

Methods: Subjects received prophylactic paracetamol or ibuprofen at 0, 6-8, and 12-16 h after vaccination, or 6-8 and 12-16 h after vaccination at 2, 3, 4, and 12months of age.

Antibody persistence and immunologic memory in children vaccinated with 4 doses of pneumococcal conjugate vaccines: Results from 2 long-term follow-up studies.

To investigate long-term antibody persistence following the administration of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV), we present results of 2 follow-up studies assessing antibody persistence following 2 3+1 schedules up to 4 (NCT00624819 - Study A) and 5 years (NCT00891176 - Study B) post-booster vaccination. In Study A, antibody persistence was measured one, 2 and 4 years post-booster in children previously primed and boosted with PHiD-CV, or primed with the 7-valent pneumococcal conjugate vaccine (7vCRM) and boosted with either PHiD-CV or 7vCRM. In Study B, PHiD-CV was co-administered with meningococcal vaccines, and pneumococcal antibody persistence was measured 2, 3 and 5 years post-booster.

Antibody Persistence in Young Children 5 Years after Vaccination with a Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C Conjugate Vaccine Coadministered with Diphtheria-Tetanus-Acellular Pertussis-Based and Pneumococcal Conjugate Vaccines.

We evaluated antibody persistence in children up to 5 years after administration of a combined Haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C (MenC)-tetanus toxoid (TT) conjugate vaccine coadministered with a pneumococcal conjugate vaccine. This is the follow-up study of a randomized trial (ClinicalTrials.gov registration no.

Predictors for diagnosis of tick-borne encephalitis infection in Poland, 2009-2010.

Background: Tick-borne encephalitis (TBE) is a viral infection with no available treatment. Due to its non-specific symptoms, TBE tends to be under-diagnosed and under-reported. We aimed to identify factors predicting TBE diagnosis to develop a diagnostic algorithm for use by physicians.

A randomized, controlled trial to assess the immunogenicity and safety of a heptavalent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, hib and meningococcal serogroup C combination vaccine administered at 2, 3, 4 and 12-18 months of age.

Background: Combination vaccines offer protection against multiple diseases with fewer injections. This study evaluated the immunogenicity and safety of an investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine (heptavalent vaccine) given as 4 doses at 2, 3, 4 and 12-18 months of age.

Methods: In this randomized, open, phase II study (NCT00970307/NCT01171989) conducted in Poland, 421 infants were enrolled to receive the heptavalent vaccine or licensed comparator vaccines.

New endemic foci of tick-borne encephalitis (TBE) identified in districts where testing for TBE was not available before 2009 in Poland.

Background: Tick-borne encephalitis (TBE) is found in limited endemic foci in Poland. Lack of diagnosis limits disease detection in non-endemic provinces.

Methods: In 2009, we enhanced TBE surveillance to confirm the location of endemic foci and inform vaccination policy.

Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine.

13-valent pneumococcal conjugate vaccine (PCV13) includes polysaccharide conjugates from six pneumococcal serotypes in addition to those in the licensed 7-valent vaccine, thereby offering expanded protection against pneumococcal disease. The phase 3 trial reported here was conducted per a regulatory requirement to evaluate the immunogenicity, safety, and tolerability of two lots of the final PCV13 formulation that differed with respect to production scale but not the manufacturing process. The anti-pneumococcal polysaccharide immunogenicity and safety/tolerability were found to be similar between the two PCV13 vaccine lots.

[Invasive pneumococcal disease in the Malopolska region of Poland, in the year 2002-2008. Is introduction of mass vaccination with conjugated pneumococcal vaccine justified?].

Unlabelled: According to the WHO pneumococcal infections are the most common cause of morbidity and mortality in children.

Objectives: The aim of the study was to establish the prevalence of pneumococcal isolates belonging to serotypes covered by 7-valent conjugated pneumococcal vaccine (7vPCV) isolated from invasive pneumococcal disease (IPD) in the Malopolska region of Poland in the years 2000-2008.

Material And Methods: Retrospective clinical and microbiological analysis was performed on invasive, laboratory confirmed pneumococcal cases in the Malopolska region, between 2000-2008.

Seropersistence of tick-borne encephalitis antibodies, safety and booster response to FSME-IMMUN 0.5 ml in adults aged 18-67 years.

A clinical study was carried out to evaluate the persistence of tick-borne encephalitis (TBE) antibodies 2 and 3 years after a primary vaccination series (three-dose regimen), and to assess the antibody response to a booster vaccination with FSME-IMMUN. Volunteers (N = 347, 18-67 years) who had received two doses of either FSME-IMMUN or Encepur adults and a third vaccination with FSME-IMMUN were enrolled. Seropositivity rates were assessed by ELISA and neutralization test (NT).

[Paediatric Expert Group on the Immunization Programme. Activities focusing on effective immunization in Poland].

The Paediatric Expert Group on the Immunization Programme was established in January 2007. It is an independent advisory body to the Minister of Health. The Expert Group consists of paediatricians from various sub-specialities.

[Incidence of Haemophilus influenzae type b meningitis in children under 5 years from Malopolska region in the years 2003-2004--prospective study].

Aim: the aim of the study was to establish the incidence of Haemophilus influenzae type b, Hib meningitis in the Malopolska province and to draw attention to the potential need for changing the rules of prophylaxis.

Material And Methods: a prospective study was carried out among children from the Malopolska province under 5 years with meningitis who were hospitalized between 1 January 2003 and 31 December 2004. All paediatric and infectious diseases wards in 24 hospitals participated in the study.

Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines.

Background: Immunogenicity of the candidate 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was assessed when coadministered with other routine pediatric vaccines including different Neisseria meningitidis serogroup C conjugate vaccines.

Methods: One thousand five hundred forty-eight healthy infants received, according to a balanced (1:1:1:1) randomization, either PHiD-CV coadministered with (1) DTPa-HBV-IPV/Hib (Infanrix hexa) and MenC-CRM (Meningitec), (2) DTPa-HBV-IPV/Hib and MenC-TT (NeisVac-C), or (3) DTPa-HBV-IPV (Infanrix penta/Pediarix) and Hib-MenC-TT (Menitorix); or 7vCRM (Prevenar/Prevnar) coadministered with DTPa-HBV-IPV and Hib-MenC-TT at 2-4-6 months of age with a booster dose at 11-18 months. Serotype-specific pneumococcal responses were measured by 22F-inhibition ELISA and opsonophagocytic (OPA) assay.

[Fever without a source. Diagnostic difficulties in invasive bacterial diseases in children observed on bacterial meningitis model].

Acute infection of the central nervous system is the most common cause of fever associated with signs and symptoms of CNS disease in children. Unfortunately most of these symptoms are non-specific. Specific signs appear very often late in the course of illness.

Nitric oxide as a prognostic marker for neurological diseases.

The potential value of the nitric oxide (NO) level as a prognostic marker in human brain diseases is investigated. Cerebrospinal fluid (CSF) collected from neurological patients was examined for NO content using electron paramagnetic resonance (EPR) spectroscopy. In adult patients with meningitis, the level of NO was higher than that in other groups of brain disorders, such as brain traumas and brain tumors.