A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I).

ABSTRACT: The novel meningococcal serogroup B vaccine (4CMenB, Bexsero(®)), recently approved in Europe and Australia, may soon be included in routine infant immunization schedules, subject to guidance from national or regional recommending bodies. In the development of 4CMenB and consistent with other newly introduced vaccines, clinical studies have shown concomitant administration with routine infant vaccines induces an incremental increase in some reactions, including fever. As this may hinder acceptability, we examined the impact of prophylactic paracetamol on the occurrence of fever and other solicited reactions, as well as the immune responses to study vaccines, in a prospectively designed study. 4CMenB was administered as a 4-dose series at 2, 3, 4, and 12 months of age concomitantly with rou

SUBMITTER: Prymula R 

PROVIDER: S-EPMC4186040 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature