Phase II meningococcal B vesicle vaccine trial in New Zealand infants

Background:A tailor-made serogroup B outer membrane vesicle vaccine was evaluated in the context of a serogroup B meningococcal epidemic dominated by Neisseria meningitidis strain B:4:P1.7b,4.Objective:To determine the safety, reactogenicity and immunogenicity in infants aged 6–8 months of a meningo...

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Veröffentlicht in:Archives of disease in childhood 2009-10, Vol.94 (10), p.745-751
Hauptverfasser: Jackson, C, Lennon, D R, Sotutu, V T K, Yan, J, Stewart, J M, Reid, S, Crengle, S, Oster, P, Ypma, E, Aaberge, I, Mulholland, K, Martin, D R
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Sprache:eng
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Zusammenfassung:Background:A tailor-made serogroup B outer membrane vesicle vaccine was evaluated in the context of a serogroup B meningococcal epidemic dominated by Neisseria meningitidis strain B:4:P1.7b,4.Objective:To determine the safety, reactogenicity and immunogenicity in infants aged 6–8 months of a meningococcal B vaccine developed against the New Zealand epidemic strain.Design, setting and participants:Observer-blind, randomised, controlled trial conducted in 296 healthy infants in Auckland, New Zealand.Intervention:Infants were randomised 4:1 to receive three doses of New Zealand candidate vaccine (epidemic strain NZ98/254, B:4:P1.7b,4) or meningococcal C conjugate vaccine at 6-weekly intervals.Main outcome measures:Immune response was determined by human complement mediated serum bactericidal assay. Sero-response was a fourfold or greater rise in titre compared to baseline, with baseline titres
ISSN:0003-9888
1468-2044
DOI:10.1136/adc.2007.132571