Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 1991 Dec;14(2):81-91; discussion 91-3.

Design of clinical trials with an outer membrane vesicle vaccine against systemic serogroup B meningococcal disease in Norway

G Bjune  1 , O Closs, L O Frøholm, J K Grønnesby, E A Høiby, H Nøkleby
Affiliations
  • PMID: 1812439

Design of clinical trials with an outer membrane vesicle vaccine against systemic serogroup B meningococcal disease in Norway

G Bjune et al. NIPH Ann. 1991 Dec.

Abstract

An outer membrane vesicle vaccine against acute, systemic disease caused by meningococci of serogroup B has been developed. The vaccine has been tested consecutively in phase I and phase II clinical trials including more than 5000 volunteers. These trials provided data on safety, immunogenicity and reactogenicity and possible effect on carriage of meningococci in the throat, and consequently formed the basis for two major protection trials; one in secondary school students and one among military recruits. The aims, design and major results of phase I and phase II studies are described as well as the design and organization of the protection trials.

PubMed Disclaimer

Substances