Abstract
In order to establish the safety of the Norwegian meningococcus B vaccine we have focused on detailed reporting of side effects in several phase II trials. We report here the results of the largest single phase II study, (step II-6) including 877 school children. The incidence of local side effects was significantly higher in the vaccine than in the placebo group, but most of them were mild and short-lasting. Mild systemic side effects were commonly reported in both groups, but more severe side effects were rare and almost equally distributed between the groups.
Publication types
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Clinical Trial
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Randomized Controlled Trial
MeSH terms
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Adolescent
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Bacterial Capsules
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Bacterial Outer Membrane Proteins / immunology*
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Bacterial Vaccines / adverse effects*
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Bacterial Vaccines / immunology
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Bacterial Vaccines / standards
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Double-Blind Method
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Fatigue / chemically induced
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Fatigue / epidemiology
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Headache / chemically induced
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Headache / epidemiology
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Humans
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Incidence
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Meningococcal Vaccines
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Norway / epidemiology
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Pain / chemically induced
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Pain / epidemiology
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Polysaccharides, Bacterial / immunology*
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Students
Substances
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Bacterial Outer Membrane Proteins
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Bacterial Vaccines
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Meningococcal Vaccines
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Polysaccharides, Bacterial
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capsular polysaccharide, meningococcal group B