Adverse events following immunisation with four-component meningococcal serogroup B vaccine (4CMenB): interaction with co-administration of routine infant vaccines and risk of recurrence in European randomised controlled trials.

ABSTRACT:

Objectives

(1) To assess if co-administration of four-component meningococcal serogroup B vaccine (4CMenB) and other routine vaccines caused an interaction increasing the risk and/or severity of adverse events following immunisation (AEFI) compared with administration at separate visits and (2) to estimate the risk of AEFI recurrence.

Design

Risk-interval design SETTING: Three randomised controlled trials conducted in Europe.

Participants

A total of 5026 healthy 2-month-old to 15-month-old infants.

Interventions

4CMenB and routine vaccines (hexavalent combined diphtheria-tetanus-acellular pertussis-inactivated polio-Haemophilus influenzae type b-hepatitis B vaccine+seven-valent pneumococcal conjugate vaccine or measles-mumps-rubella-varicella vaccine) administe

SUBMITTER: Zafack JG 

PROVIDER: S-EPMC6530311 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature