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• W1984173487 abstract "<h3>Background:</h3> A tailor-made serogroup B outer membrane vesicle vaccine was evaluated in the context of a serogroup B meningococcal epidemic dominated by <i>Neisseria meningitidis</i> strain B:4:P1.7b,4. <h3>Objective:</h3> 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. <h3>Design, setting and participants:</h3> Observer-blind, randomised, controlled trial conducted in 296 healthy infants in Auckland, New Zealand. <h3>Intervention:</h3> 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. <h3>Main outcome measures:</h3> 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 <4 required to increase to ⩾8. Blood samples were taken before vaccination, 6 weeks after dose two, and 4 weeks after dose three. Local and systemic reactions were recorded for 7 days following vaccination. <h3>Results:</h3> Sero-response to the candidate vaccine strain, NZ98/254, was demonstrated in 74% of vaccinees (95% CI: 68% to 80% intention-to-treat; 67% to 79% per protocol) after three doses of New Zealand candidate vaccine. No meningococcal C conjugate vaccine recipients were sero-responders to NZ98/254 after three doses. Both vaccines were well tolerated with no vaccine related serious adverse events. <h3>Conclusions:</h3> Our data indicate that the New Zealand candidate vaccine administered in three doses to this group of 6–8-month-old infants was safe and immunogenic against the candidate vaccine strain NZ98/254 (<i>Neisseria meningitidis</i> B:4:P1.7b,4)." @default.
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• W1984173487 date "2008-10-06" @default.
• W1984173487 modified "2023-10-14" @default.
• W1984173487 title "Phase II meningococcal B vesicle vaccine trial in New Zealand infants" @default.
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• W1984173487 doi "https://doi.org/10.1136/adc.2007.132571" @default.
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