The Norwegian meningococcal group B outer membrane vesicle vaccine: side effects in phase II trials.
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.
Nøkleby
H
H
National Institute of Public Health, Oslo.
Feiring
B
B
D000293:Adolescent; D016667:Bacterial Capsules; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology*; D001428:Bacterial Vaccines / Q000009:adverse effects* / Q000276:immunology / Q000592:standards; D004311:Double-Blind Method; D005221:Fatigue / Q000139:chemically induced / Q000453:epidemiology; D006261:Headache / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D022401:Meningococcal Vaccines; D009664:Norway / Q000453:epidemiology; D010146:Pain / Q000139:chemically induced / Q000453:epidemiology; D011135:Polysaccharides, Bacterial / Q000276:immunology*; D013334:Students
D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D022401:Meningococcal Vaccines; D011135:Polysaccharides, Bacterial; C039455:capsular polysaccharide, meningococcal group B