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Titolo:
CLINICAL-EXPERIENCE OF A TRICOMPONENT ACELLULAR PERTUSSIS-VACCINE COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS FOR PRIMARY VACCINATION IN 22,505 INFANTS
Autore:
SCHMITT HJ; SCHUIND A; KNUF M; BEUTEL K; SCHULTEWISSERMANN H; GAHR M; SCHULT R; FOLKENS J; RAUH W; BOGAERTS H; BORK HL; CLEMENS R;
Indirizzi:
CHRISTIAN ALBRECHTS UNIV KIEL,CHILDRENS HOSP,SCHWANENWEG 20 D-24105 KIEL GERMANY UNIV MAINZ,CHILDRENS HOSP D-6500 MAINZ GERMANY MUNICIPAL HOSP KREFELD GERMANY UNIV GOTTINGEN,CHILDRENS HOSP D-3400 GOTTINGEN GERMANY CHILDRENS HOSP OFFENBURG GERMANY PEDIAT AMBULANCE FLENSBURG FLENSBURG GERMANY CHILDRENS HOSP,MUTTERHAUS BORROMAERINNEN TRIER GERMANY SMITHKLINE BEECHAM BIOL RIXENSART BELGIUM
Titolo Testata:
The Journal of pediatrics
fascicolo: 5, volume: 129, anno: 1996,
pagine: 695 - 701
SICI:
0022-3476(1996)129:5<695:COATAP>2.0.ZU;2-J
Fonte:
ISI
Lingua:
ENG
Soggetto:
CHILDREN; IMMUNOGENICITY; IMMUNIZATION; JAPAN; REACTOGENICITY; 3-MONTH-OLD; ANTIBODIES; BOOSTER; ASSAY;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
30
Recensione:
Indirizzi per estratti:
Citazione:
H.J. Schmitt et al., "CLINICAL-EXPERIENCE OF A TRICOMPONENT ACELLULAR PERTUSSIS-VACCINE COMBINED WITH DIPHTHERIA AND TETANUS TOXOIDS FOR PRIMARY VACCINATION IN 22,505 INFANTS", The Journal of pediatrics, 129(5), 1996, pp. 695-701

Abstract

Objectives: To assess the safety and tolerability of 12 lots of SmithKline Beecham Biologicals' diphtheria-tetanus-tricomponent acellular pertussis vaccine (DTaP) in a large cohort of 22,000 vaccinees, with detailed analyses of reactivity, immunogenicity, and immune response to pertussis toxin in subsets. Methods: In a prospective, double-blind, multicenter trial in Germany, 22,505 healthy infants received three vaccinations of DTaP at age 3, 4, and 5 months. Serious adverse events were followed for 1 month after each vaccination, and neurologic events for 1 year or longer, Serum IgG antibodies were assayed before vaccination and 1 month after vaccination. Results: After 67,000 doses, 153 serious adverse events (0.23%) were reported, 8 considered possibly related, and 5 related to vaccination, including 1 hypotonic-hyporesponsive episode, Incidence rates of sudden infant death syndrome (7; 0.01%)or acute neurologic events (20; 0.030%) were no higher than expected and not considered to be related to vaccination, Redness and swelling of 20 mm or greater occurred after 44 (0.6%) and 40 (0.6%) of the 7270doses, respectively, and high fever (>39,5 degrees C) in 6 (0.08%) subjects within 48 hours of vaccination. in the immunogenicity analysis of 580 infants, 98% responded to pertussis toxin, 96% to filamentous hemagglutinin, and 98% to pertactin, In an additional 5712 infants, theresponse rate to pertussis toxin was 99%. Conclusions: In a large cohort of 22,505 infants vaccinated, SmithKline Beecham Biologicals' tricomponent DTaP vaccine was shown to be safe, well-tolerated, and immunogenic for all component antigens.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 26/11/20 alle ore 19:13:50