[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.
Statens institutt for folkehelse, Oslo.
G
G
Bjune
H
H
Nøkleby
B
B
Hareide
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.