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  • 1
    ISSN: 1432-1076
    Keywords: Key words Pertussis ; Monovalent ; multicomponent acellular pertussis vaccine ; Immunogenicity ; Reactogenicity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Immunization against pertussis has been re-recommended for healthy children in Germany in 1991. In addition the former restriction of immunizing only in the first 2 years of life was abolished. In children born before 1991 immunization rates against pertussis were 15% or less. With the new recommendations physicians are now faced with an increasing demand of parents for catch-up vaccinations in these children. Since they were immunized against diphtheria and tetanus previously monovalent pertussis vaccines are needed for this indication. Therefore a monovalent, multicomponent acellular pertussis vaccine was studied in 249 German children 15 months to 6 years of age. Three doses were administered at 6–10 week intervals. Reactogenicity and antibody responses against the vaccine antigens pertussis toxin (PT), filamentous haemagglutinin (FHA), 69-kd antigen (pertactin) and fimbriae-2 (agglutinogen) were investigated. Local and systemic reactions were minimal in frequency and severity. Antibody responses against all vaccine antigens were pronounced with 93%–100% of vaccinees demonstrating at least four fold titre rises above pre-immunization after the third dose. These findings indicate that this monovalent, multicomponent acellular pertussis vaccine with excellent immunogenicity and low reactogenicity is an appropriate candidate for closing immunization gaps in older children in countries with previously low vaccination rates against pertussis. Based on the results of this study the monovalent acellular pertussis vaccine was licensed in Germany in January 1994.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1432-1076
    Keywords: Pertussis ; Monovalent, multicomponent acellular pertussis vaccine ; Immunogenicity ; Reactogenicity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Immunization against pertussis has been re-recommended for healthy children in Germany in 1991. In addition the former restriction of immunizing only in the first 2 years of life was abolished. In children born before 1991 immunization rates against pertussis were 15% or less. With the new recommendations physicians are now faced with an increasing demand of parents for catch-up vaccinations in these children. Since they were immunized against diphtheria and tetanus previously monovalent pertussis vaccines are needed for this indication. Therefore a monovalent, multicomponent acellular pertussis vaccine was studied in 249 German children 15 months to 6 years of age. Three doses were administered at 6–10 week intervals. Reactogenicity and antibody responses against the vaccine antigens pertussis toxin (PT), filamentous haemagglutinin (FHA), 69-kd antigen (pertactin) and fimbriae-2 (agglutinogen) were investigated. Local and systemic reactions were minimal in frequency and severity. Antibody responses against all vaccine antigens were pronounced with 93%–100% of vaccinees demonstrating at least four fold titre rises above pre-immunization after the third dose. These findings indicate that this monovalent, multicomponent acellular pertussis vaccine with excellent immunogenicity and low reactogenicity is an appropriate candidate for closing immunization gaps in older children in countries with previously low vaccination rates against pertussis. Based on the results of this study the monovalent acellular pertussis vaccine was licensed in Germany in January 1994.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1439-0973
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Summary To evaluate the reactogenicity and immunogenicity of aHaemophilus influenzae type b conjugate vaccine (HbOC) and of a tricomponent acellular pertussis vaccine (DTaP) when injected simultaneously into either contralateral arms or into contralateral thighs, 110 infants were enrolled to receive three doses of DTaP at 3, 4, and 5 months and two HbOC doses at 3 and 5 months of age. Administration of either of the two vaccines into arms was associated with significantly more local side effects than administration into thighs. There was no difference in geometric mean concentration (GMC) values for any of the four vaccine antigens between subjects who had been vaccinated into arms or thighs. After immunization, all children had protective antibody titers to diphtheria toxin. While post vaccination the mean anti-tetanus toxoid GMC was ≥ 1.25 IU/ml, there was no significant rise as compared to the GMC before vaccination. GMCs of antibodies against the various pertussis antigens were similar to those observed before with the same DTaP vaccine. The simultaneous administration of DTaP and HbOC was safe and immunogenic irrespective of the site of vaccine administration, but significantly more local reactions occurred when vaccines were injected into arms.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1433-0474
    Keywords: Schlüsselwörter Azelluläre Pertussisvakzine ; Monovalent ; Boosterimpfung ; Immunogenität ; Verträglichkeit ; Key words Acellular pertussis vaccine ; Monovalent ; Booster immunization ; Immunogenicity ; Reactogenicity ; Pre-school age
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary Aim of the study was to evaluate reactogenicity and immunogenicity of a monovalent, acellular 4-component pertussis vaccine (pertussis toxin = PT, filamentous haemagglutinin = FHA, pertactin, fimbriae-type 2) when given as a booster dose after primary immunization with the same vaccine. Methods: After 3 immunizations against pertussis with 6 week intervals at the age of 15 months of 6 years, 165 children received a booster dose after a mean of 15 months. The course following immunization was documented in a standardized parent diary. Specific antibodies against vaccine antigens were determined from serum specimens obtained before and 4 weeks after the dose. Results: As expected antibody values before the booster dose had decreased compared to post 3 rd dose values but still were 4 to 40-fold above pre 1 st dose values. The 4 th dose resulted in a pronounced boost with 9 (fimbriae type 2) to 24-fold (pertactin) titer rises. Antibody values against PT, FHA and Fimbriae-type 2 positively correlated with age of the vaccinees. The booster dose was well tolerated as were immunizations during the primary series before. Local reactions at the immunization site ranged from 2,6 % (swelling) to 35,8 % (redness) and were generally mild. Systemic reactions occurred at a maximal rate of 15,1 % (temperature ≥ 38 °C). Neither local nor systemic reactions were correlated with age of the vaccinees. Conclusions: This monovalent, acellular 4-component vaccine has been licensed in Germany since January 1994 for immunizations against pertussis for children at least 15 months of age. It showed excellent reactogenicity and immunogenicity for a broad age range (4 th dose was applicated up to the 8 th year of life). Since the presence of specific antibodies before immunization did not influence immunogenicity or reactogenicity, immunizations against pertussis with this vaccine can be commenced or continued after previous doses with whole-cell vaccine any time without previous antibody determinations.
    Notes: Zusammenfassung Ziel der Untersuchung: Bestimmung von Verträglichkeit und Immunogenität einer Boosterimpfung (4. Dosis) gegen Pertussis mit einer monovalenten, azellulären 4-Komponenten-Vakzine (Pertussistoxin = PT, Filamentöses Hämagglutinin = FHA, Pertaktin, Fimbrientyp 2). Vorausgegangen war eine Grundimmunisierung mit der gleichen Vakzine. Methode: 165 Kinder, die im Alter von 15 Monaten bis 6 Jahren 3 mal im Abstand von mindestens 6 Wochen die Impfung gegen Pertussis erhalten hatten, erhielten im Mittel 15 Monate später eine Auffrischungsimpfung. Die Verträglichkeit der Immunisierung wurde in einem standardisierten Tagebuch erfaßt. In prävakzinalen und 4 Wochen nach der Impfung entnommenen Blutproben wurden die spezifischen Antikörper gegen die in der Vakzine enthaltenen Antigene von Bordetella pertussis bestimmt. Ergebnisse: Die Antikörpertiter vor der 4. Dosis waren im Vergleich zu den Werten nach der 3. Impfung erwartungsgemäß deutlich abgefallen, lagen aber 4- bis 40 fach über dem Ausgangsniveau. Die Auffrischungsimpfung resultierte in einer ausgeprägten Boosterung mit 9 fachen (Fimbrien-Typ 2) bis 24 fachen (Pertaktin) Titeranstiegen. Gegenüber den Antigenen PT, FHA und Fim-2 korrelierten die Antikörperhöhen positiv mit dem Alter der Impflinge. Die Vakzine wurde, wie schon im Verlauf der Grundimmunisierung beobachtet, sehr gut vertragen. Die lokalen Nebenwirkungen an der Impfstelle lagen zwischen 2,6 (Schwellung) und 35,8 % (Rötung) und wurden in der Regel von den Impflingen als geringfügig bewertet. Die systemischen Nebenwirkungen betrugen maximal 15,1 % (Temperatur ≥ 38 °C). Weder lokale noch systemische Nebenwirkungen zeigten eine Altersabhängigkeit. Schlußfolgerungen: Die von uns untersuchte monovalente, azelluläre 4-Komponenten-Vakzine ist seit Januar 1994 für Erst- und Folgeimpfungen gegen Pertussis ab dem 15. Lebensmonat zugelassen. Sie zeigt für ein breites Altersspektrum (bei Gabe der 4. Dosis bis ins 8. Lebensjahr) eine sehr gute Verträglichkeit und Immunogenität. Da prävakzinal vorhandene Antikörper gegen Pertussisantigene keine Beeinträchtigung von Immunogenität oder Verträglichkeit der Impfungen zeigten, kann mit diesem Impfstoff bei Kindern ohne vorherige Antikörperbestimmung jederzeit eine Immunisierung gegen Pertussis durchgeführt oder eine bereits mit Ganzkeimvakzine begonnene Impfung fortgesetzt werden.
    Type of Medium: Electronic Resource
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