Research in context
Evidence before this study
We searched MEDLINE, Scopus, and Cochrane online databases from inception to Feb 28, 2017, for previously published systematic reviews and meta-analyses on the immunogenicity or safety of meningococcal serogroup B vaccine (4CMenB) in children or adolescents using the following search terms, without language restrictions: “(4CMenB OR rMenB+OMV OR meningococcal B*)” AND “vaccin*” AND “(immunogenicity OR efficacy OR effectiveness OR safety OR adverse event*)” AND “(systematic review OR meta-analysis). Our literature search showed that no systematic reviews or meta-analyses had been done on the immunogenicity and safety of the 4CMenB vaccine before this study. Results of single studies are difficult to interpret, and thus uncertainties remain about the lowest number of doses required to induce a satisfactory short-term and long-term immune response.
Added value of this study
This is the first meta-analysis of randomised controlled trials on both the immunogenicity and safety of 4CMenB vaccine in children and adolescents. We found that 30 days after the primary immunisation course, 4CMenB vaccination of children and adolescents induced seroconversion against all four tested strains in more than 91% of individuals. The addition of a booster dose, which is recommended for children in several countries, re-enhanced the proportion of individuals who achieved seroconversion (≥93% for all strains). However, the immunogenicity remained high 6 months after the booster dose for the 5/99 and M10713 strains only, whereas the proportion of patients who achieved seroconversion against the 44/76-SL and NZ98/254 strains returned to values similar to those observed 6 months after the primary course. In the overall comparative meta-analyses, 4CMenB had increased immunogenicity (short-term and persistence) compared with rMenB against strain NZ98/254 (for which rMenB had inadequate response).
Implications of all the available evidence
With an acceptable short-term safety profile, high immunogenicity in children and adolescents within the first months after vaccination, and adequate-to-high persistence of immunogenicity (against all tested strains in adolescents and against three of four strains in children), 4CMenB might be a crucial tool to control meningococcal B disease. The primary course is sufficient to achieve a satisfactory immune response within 30 days of vaccination. A booster dose is required for children to prolong the protection against strain M10713, and the long-term immunogenicity against strain NZ98/254 remains suboptimal. The clinical significance of the poor persistence against the NZ98/254 strain, and coverage against outbreak strains, require further study.