Immunogenicity and safety of the 4CMenB and MenACWY-CRM meningococcal vaccines administered concomitantly in infants: A phase 3b, randomized controlled trial

• DOI: 10.1016/j.vaccine.2018.10.096
• Publication Date: 2018-11-07T12:44:44Z
• Authors: Mercedes Macias P...; Angela Gentile; Jorge Alejandro V...; Alejandro Capdevila; Angel Minguez; Monica Carrascal; Arnold Willemsen; Chiranjiwi Bhusal; Daniela Toneatto
• Keywords: Meningococcal vaccine; Vaccine safety

Invasive meningococcal disease has its highest incidence in infants. Co-administration of serogroup B (4CMenB) and quadrivalent conjugate (MenACWY-CRM) vaccines could protect against 5 clinically-relevant serogroups. This phase 3b, open, multicenter study (NCT02106390), conducted Mexico Argentina, enrolled randomized (1:1:1) 750 healthy infants to receive either 4CMenB co-administered with MenACWY-CRM (4CMenB/MenACWY group), (4CMenB or alone (MenACWY group) at ages 3, 5, 7 13 months. Non-inferiority immune responses co-administration single administration was assessed 1 month post-booster dose (primary objective). Immunogenicity evaluated pre- post-primary booster vaccinations using human serum bactericidal assay (hSBA). Safety assessed. At vaccination, between-group hSBA geometric mean titer (GMT) ratios ranged from 0.89 1.03 for strains (group 4CMenB/MenACWY over 4CMenB), 1.05 2.48 ACWY serogroups MenACWY). The lower limit the 2-sided 95% confidence intervals all GMT >0.5; primary objective demonstrated. Across groups strains, 68–100% 87–100% children had titers ≥5 respectively. For ACWY, ≥96% (post-primary vaccination) ≥98% (post-booster ≥4. Post-booster GMTs increased ≥5.99-fold pre-booster values each strain/serogroup. Solicited adverse events (AEs) were more frequent than MenACWY; other AEs similar between groups. Serious reported 6, 13, 11 participants 4CMenB/MenACWY, 4CMenB, MenACWY, respectively; 4CMenB) considered vaccine-related. Immune elicited by non-inferior immunization. immunogenic well tolerated ClinicalTrials.gov: NCT02106390. An Audio Summary linked this article that can be found on Figshare https://figshare.com/articles/Immunogenicity_and_safety_of_the_4CMenB_and_MenACWY-CRM_meningococcal_vaccines_administered_concomitantly_in_infants_-_A_phase_3b_randomized_controlled_trial/9945050.