Safety and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine coadministered with DTPw-HBV/Hib and poliovirus vaccines.

The safety and reactogenicity profiles of the 10-valent pneumococcal conjugate vaccine, PHiD-CV, and 7vCRM were comparable within the Philippines and Poland when coadministered as a booster dose with DTPw-HBV/Hib and poliovirus vaccines to toddlers primed with the same vaccines. Robust immune responses for all 10 vaccine pneumococcal serotypes and protein D following PHiD-CV booster vaccination were indicative of effective priming.

Influenza vaccine concurrently administered with a combination measles, mumps, and rubella vaccine to young children.

Children aged 11 to <24 months received 2 intranasal doses of live attenuated influenza vaccine (LAIV) or placebo, 35+/-7 days apart. Dose 1 was administered concomitantly with a combined measles, mumps, and rubella vaccine (Priorix). Seroresponses to measles and mumps were similar between groups. Compared with placebo, response rates to rubella in LAIV+Priorix recipients were statistically lower at a 15 IU/mL threshold (83.9% vs 78.0%) and the prespecified noninferiority criteria were not met. In a post hoc analysis using an alternate widely accepted threshold of 10 IU/mL, the noninferiority criteria were met (93.4% vs 89.8%). Concomitant administration with Priorix did not affect the overall influenza protection rate of LAIV (78.4% and 63.8% against antigenically similar influenza strains and any strain, respectively).

Safety and immunogenicity of a DTaP-IPV(Vero) (serum-free) combination vaccine in comparison to DTaP-IPV(Mkc) when administered simultaneously with Haemophilus influenzae type B conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age.

In a phase III, double blind, randomized, noninferiority, multi-centre clinical trial, 817 infants were included and randomly assigned to vaccination with DTaP-IPV(Vero) (N=410) or DTaP-IPV(Mkc) (N=407) vaccines (Statens Serum Institut (SSI), Denmark) in the right thigh. All infants were vaccinated with Act-HIB (Sanofi Pasteur, France) in the left thigh at the same time. The vaccination schedule was 2, 3.5, 5 and 16 months and serum samples were obtained at 6, 16 and 17 months. The primary objective was to demonstrate noninferiority of DTaP-IPV(Vero) to DTaP-IPV(Mkc) as regards immunological protection against polio virus types 1, 2 and 3. Furthermore, the immunogenicity of all vaccine antigens and the safety profile of the vaccines were assessed. The study demonstrated that DTaP-IPV(Vero) was noninferior to DTaP-IPV(Mkc). All antibody concentrations/titres remained at an acceptable level from the end of the primary vaccination series (i.e. 2, 3.5 and 5 months) until the time of the booster vaccination at 16 months. A good booster response was, furthermore, demonstrated for all antigens. No vaccine-related serious adverse events and no injection site granulomas or swelling of the entire thigh occurred. The frequencies of local injection site erythema and swelling as well as systemic adverse events such as fever, irritability, somnolence and decreased appetite were low and acceptable in both treatment groups. In conclusion, DTaP-IPV(Vero) is immunogenic and safe for primary vaccination and for booster vaccination of healthy children.

Colonisation of the gastrointestinal tract by probiotic L. rhamnosus strains in acute diarrhoea in children.

Lactobacillus rhamnosus (573L/1-3) strains are considered effective in the treatment of rotaviral diarrhoea in children. The colonisation of the gastrointestinal (G.I.) tract by the Lactobacillus rhamnosus strains and the determining factors are discussed reporting data of a prospective, double-blinded, placebo-controlled randomized study in children between the 2nd month and 6th year of life with acute diarrhoea lasting not longer than 5 days. The examined strains were detected in 37/46 (80.43%) patients after 5 days and in 19/46 (41.3%) patients after 14 days since the start of the treatment. L. rhamnosus 573L/1 strain colonised the G.I. tract more persistently. L. rhamnosus strains are effective in colonising the G.I. tract during acute diarrhoea. Persistence of colonisation is dependent on the properties of administered probiotic strains.

[Croup in children--results of prospective, multicenter observation]. / Przyczyny ostrej dusznosci krtaniowej u dzieci--wyniki prospektywnych wieloosrodkowych obserwacji.

UNLABELLED: Croup syndrome is an urgent and frequent reason for hospitalization of children. MATERIAL AND METHODS: 632 children with croup syndrome (422 boys and 210 girls aged 2 months-17 years) admitted to 15 pediatric departments in Lower Silesia were prospectively observed for 12 months (from April 2001 to March 2002). We conducted prospective survey of clinical and laboratory data from all study centers. RESULTS: Following diagnoses were accepted as the croup syndrome: subglottic laryngitis in 482 patients (75.4%), laryngotracheobronchitis in 75 (11.8%), laryngitis in 50 (7.8%) and epiglottitis in 20 children (3%). The most severe course was observed in children with epiglottitis. Four of them required airway intervention and had endotracheal intubation. H. influenzae b was cultured from blood of one patient. The most cases of epiglottitis occurred in the 3rd year of life (45%). CONCLUSIONS: 1. The most common reason of croup was subglottic laryngitis. 2. Epiglottitis was rare with serious course of disease; frequency was comparable with the frequency seen in European countries before the implementation of Hib vaccine. The routine use of Hib vaccine in Poland may prevent from children life threatening epiglottis cases.

[Treatment of croup syndrome in children in Poland: results of the prospective multi-center observation]. / Przeglad sposobów leczenia dzieci z podglosniowym zapaleniem krtani w swietle prospektywnych wieloosrodkowych obserwacji.

UNLABELLED: The aim of the study was to estimate treatment practice in hospital management of croup syndrome (laryngitis subglottica) in children in Poland. MATERIAL AND METHODS: During the period of 12 months, we have prospectively observed 482 children with croup syndrome admitted to 15 pediatric departments in Lower Silesia (south-west region of Poland). Data concerning epidemiology, clinical course and treatment were collected from uniform observation cards. There were 326 boys and 156 girls aged between 2 and 174 months in our study. RESULTS: Among 482 observed children, received glucocorticoids 424 (88%) mainly parenteral, L-epinephrine--211 (43.8%), mist therapy--241 (50%), antihistamines--308 (63.9%), antibiotics--280 (58.1%). Children treated with antibiotics were younger (p=0.0316), their temperature, amount of leukocytes and value of C-reactive protein was higher when compared with those not treated (p=0.0002; p=0.0081, p=0.0172 respectively). CONCLUSIONS: Children in Lower Silesia with croup syndrome were treated in agreement with recent standards with glucocorticoids and/or epinephrine. There was an excessive usage of antihistamines which have no established treatment role. It seems that in many cases antibiotic treatment could have been avoided.

Passive acquired immunity against measles in infants born to naturally infected and vaccinated mothers.

BACKGROUND: Currently, the majority of newborns in Poland are born to mothers who have been immunized against measles. The aim of this study was to compare the maternal measles antibody titers of infants born to mothers who had been infected by measles wild virus (group I) with those born to mothers who had been vaccinated (group II). MATERIAL/METHODS: Serum samples were tested for measles antibodies from 79 infants in the 7th month of life and from 27 mothers between 17 and 41 years of age. Two commercial enzyme immunoassays (EIA) and a plaque neutralization test (PNT) were used. RESULTS: Only 12.7% of all infants showed measles antibodies in EIA. However, antibodies could be detected by PNT in all the infants, although only 36.6% showed titers of >1:8, which corresponds to protective antibody values of >0.2 IU/ml. The mean geometrical titer was significantly higher among infants from group I than in group II (1:7.16 vs. 1:3.71, p=0.0038). Protective antibody titers were detected in 50% of infants from group I and only 18.2% in group II (p<0.02). CONCLUSIONS: Passive acquired immunity in infants born to mothers who have had measles lasts longer than in infants born to vaccinated mothers. Nearly two thirds of infants (65.4%) in the 7th month of life did not have sufficient maternally derived neutralizing antibodies to protect against measles. Our data suggest that the recommended age for the first dose of measles vaccine during measles epidemics should be lowered to 9 months, with re-vaccination at 12-15 months.