[Clinical trials of the new Norwegian vaccine against diseases caused by Meningococcus B].
Since 1974 Norway has experienced an epidemic of meningococcal disease. In October 1986 the National Institute of Public Health decided to develop and test out a vaccine against group B meningococci. This paper describes how the vaccine was tested through phase I and II trials, and how problems of safety and informed consent were handled. Two major protection trials are currently in progress. 130,000 secondary school students have volunteered for a study simulating the use of a vaccine in the long-term protection of an age group at risk. Military recruits are involved in a study where instant protection is important, as in a situation where the vaccine is used in the vicinity of an outbreak of the disease. 20,000 soldiers are included so far, and the study will ultimately include 70,000.
Bjune
G
G
Statens institutt for folkehelse, Oslo.
Nøkleby
H
H
Hareide
B
B
D001428:Bacterial Vaccines / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D006801:Humans; D008585:Meningitis, Meningococcal / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines; D009664:Norway / Q000453:epidemiology
D001428:Bacterial Vaccines; D022401:Meningococcal Vaccines
Klinisk utprøving av den nye norske vaksinen mot meningokokk-B-sykdom.