Immunogenicity and Tolerability of Recombinant Serogroup B Meningococcal Vaccine Administered With or Without Routine Infant Vaccinations According to Different Immunization Schedules

摘要: Context In the absence of an effective vaccine, serogroup B Neisseria meningitidis (MenB) remains a major cause invasive disease in early childhood developed countries. Objective To determine immunogenicity and reactogenicity multicomponent MenB vaccine (4CMenB) routine infant vaccines when given either concomitantly or separately. Design, Setting, Participants Phase 2b, multicenter, open-label, parallel-group, randomized controlled study 1885 infants enrolled at age 2 months from August 2008 to July 2010 Europe. Intervention were 2:2:1:1 receive (1) 4CMenB 2, 4, 6 with (7-valent pneumococcal combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, Haemophilus influenzae type b vaccines); (2) 3, 5, 7 months; (3) 4 (4) alone months. Main Outcome Measures Percentage participants human complement serum bactericidal activity (hSBA) titer 1:5 greater against 3 strains specific for antigens (NZ98/254, 44/76-SL, 5/99). Results After three vaccinations, 99% more hSBA titers 44/76-SL 5/99. For NZ98/254, this proportion was 79% (95% CI, 75.2%-82.4%) vaccination vaccines, 86.1% 82.9%-89.0%) without 81.7% 76.6%-86.2%) vaccines. Responses noninferior all antigens, except responses pertactin serotype 6B polysaccharide. Fever seen following 26% (158/602) 41% (247/607) doses administered alone, compared 23% (69/304) 36% (109/306) after 51% (306/605) 61% (380/624) together. Conclusion A is immunogenic reference age, producing minimal interference response vaccinations. Trial Registration clinicaltrials.gov Identifier: NCT00721396