Safety review:: Two outer membrane vesicle (OMV) vaccines against systemic Neisseria meningitidis serogroup B disease

被引：65

作者：

Nokleby, H.

Aavitsland, P.

O'Hallahan, J.

Feiring, B.

Tilman, S.

Oster, P.

机构：

[1] NIPH, N-0403 Oslo, Norway

[2] ESR, Porirua, New Zealand

[3] Novartis Vaccines BCDM, Amsterdam, Netherlands

[4] Novartis Vaccines & Diagnost, Siena, Italy

来源：

VACCINE | 2007年 / 25卷 / 16期

关键词：

reactogenicity; neurological adverse events; epidemiological follow-up;

D O I：

10.1016/j.vaccine.2007.01.022

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

MenBvac is an OMV vaccine against systemic serogroup B Neisseria meningitidis disease. MenBvac was developed for control of a B:15:P1.7,16 subtype epidemic in Norway and administered to 180,000 subjects in 28 clinical studies. MeNZB, a daughter vaccine of MenBvac, was developed for a clonal B:4:P1.7b,4 epidemic in New Zealand and administered to I million people < 20 years. The vaccines were similar regarding reactogenicity profile. Serious adverse events (SAEs) in general and particularly neurologic SAEs were very rare. Despite frequently reported local reactions and fever in those under 5 years, these OW-based vaccines containing 25 mu g antigen can be considered safe for use in all age groups. (c) 2007 Elsevier Ltd. All rights reserved.

引用

页码：3080 / 3084

页数：5

共 12 条

[1]

AAVITSLAND P, 1993, P 18 INT C CHEM, P749

[2] SEQUELAE FROM BACTERIAL-MENINGITIS AND THEIR RELATION TO THE CLINICAL CONDITION DURING ACUTE ILLNESS, BASED ON 667 QUESTIONNAIRE RETURNS .2. [J].