Immunogenicity and safety of the 4CMenB and MenACWY-CRM meningococcal vaccines administered concomitantly in infants: A phase 3b,randomized controlled trial |
| |
| Affiliation: | 1. Instituto Nacional de Pediatría, Insurgentes Cuicuilco, 04530 Mexico City, Mexico;2. Hospital de Niños “Ricardo Gutiérrez”, Gallo 1330, Ciudad Autónoma de Buenos Aires, Argentina;3. Asociacion de Investigacion Pediatrica Y Adultos (AINPAD A.C.), Montaña Monarca No 31 Consultorio 209 y 2010 Col Jesús del Monte Morelia, Michoacán CP58350, Mexico;4. Paideia, Investigacion Clinica en Pediatria, Salguero 2835, Ciudad Autónoma de Buenos Aires, Argentina;5. Hospital Nuestra Señora de la Misericordia del Nuevo Siglo, Belgrano 1502, 5000 Córdoba, Argentina;6. CAIMED Investigación en Salud S.A de C.V, Calle de Manzanillo # 100 Colonia Roma Sur, Piso 2 Delegación Cuauhtémoc, México City, Mexico;7. Plus100 B.V. c/o GSK, Hullenbergweg 83-85, 1101 CL Amsterdam, the Netherlands;8. GSK, Via Fiorentina, 1, 53100 Siena, Italy |
| |
| Abstract: | BackgroundInvasive 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 meningococcal serogroups.MethodsThis phase 3b, open, multicenter study (NCT02106390), conducted in Mexico and Argentina, enrolled and randomized (1:1:1) 750 healthy infants to receive either 4CMenB co-administered with MenACWY-CRM (4CMenB/MenACWY group), 4CMenB (4CMenB group), or MenACWY-CRM alone (MenACWY group) at ages 3, 5, 7 and 13 months. Non-inferiority of immune responses of co-administration to single administration of vaccines was assessed at 1 month post-booster dose (primary objective). Immunogenicity was evaluated pre- and 1 month post-primary and booster vaccinations using human serum bactericidal assay (hSBA). Safety was assessed.ResultsAt 1 month post-booster vaccination, between-group hSBA geometric mean titer (GMT) ratios ranged from 0.89 to 1.03 for serogroup B strains (group 4CMenB/MenACWY over 4CMenB), and from 1.05 to 2.48 for ACWY serogroups (group 4CMenB/MenACWY over MenACWY). The lower limit of the 2-sided 95% confidence intervals for all GMT ratios was >0.5; the primary objective was demonstrated. Across all groups and serogroup B strains, 68–100% and 87–100% of children had hSBA titers ≥5 at 1 month post-primary and booster vaccination, respectively. For serogroups ACWY, ≥96% (post-primary vaccination) and ≥98% (post-booster vaccination) of children in all groups had hSBA titers ≥4. Post-booster vaccination, GMTs increased ≥5.99-fold from pre-booster values for each strain/serogroup. Solicited adverse events (AEs) were more frequent in groups 4CMenB/MenACWY and 4CMenB than in MenACWY; incidence of all other AEs was similar between groups. Serious AEs were reported for 6, 13, and 11 participants in groups 4CMenB/MenACWY, 4CMenB, and MenACWY, respectively; 1 (group 4CMenB) was considered vaccine-related.ConclusionImmune responses elicited by co-administration of 4CMenB and MenACWY-CRM was non-inferior to single immunization. Co-administration of vaccines was immunogenic and well tolerated in infants.ClinicalTrials.gov: NCT02106390.An Audio Summary linked to 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. |
| |
| Keywords: | Meningococcal vaccination Infants Co-administration 4CMenB MenACWY-CRM AE" },{" #name" :" keyword" ," $" :{" id" :" k0035" }," $$" :[{" #name" :" text" ," _" :" adverse event ANOVA" },{" #name" :" keyword" ," $" :{" id" :" k0045" }," $$" :[{" #name" :" text" ," _" :" analysis of variance CI" },{" #name" :" keyword" ," $" :{" id" :" k0055" }," $$" :[{" #name" :" text" ," _" :" confidence interval CRM" },{" #name" :" keyword" ," $" :{" id" :" k0065" }," $$" :[{" #name" :" text" ," _" :" non-toxic diphtheria cross-reacting mutant fHbp" },{" #name" :" keyword" ," $" :{" id" :" k0075" }," $$" :[{" #name" :" text" ," _" :" factor H binding protein GCP" },{" #name" :" keyword" ," $" :{" id" :" k0085" }," $$" :[{" #name" :" text" ," _" :" Good Clinical Practice GMR" },{" #name" :" keyword" ," $" :{" id" :" k0095" }," $$" :[{" #name" :" text" ," _" :" geometric mean ratio GMT" },{" #name" :" keyword" ," $" :{" id" :" k0105" }," $$" :[{" #name" :" text" ," _" :" geometric mean titer hSBA" },{" #name" :" keyword" ," $" :{" id" :" k0115" }," $$" :[{" #name" :" text" ," _" :" serum bactericidal assay using human complement IMD" },{" #name" :" keyword" ," $" :{" id" :" k0125" }," $$" :[{" #name" :" text" ," _" :" invasive meningococcal disease LL" },{" #name" :" keyword" ," $" :{" id" :" k0135" }," $$" :[{" #name" :" text" ," _" :" lower limit NadA" },{" #name" :" keyword" ," $" :{" id" :" k0145" }," $$" :[{" #name" :" text" ," _" :" Neisserial adhesin A NHBA" },{" #name" :" keyword" ," $" :{" id" :" k0155" }," $$" :[{" #name" :" text" ," _" :" neisserial heparin binding antigen Por A" },{" #name" :" keyword" ," $" :{" id" :" k0165" }," $$" :[{" #name" :" text" ," _" :" porin A SAE" },{" #name" :" keyword" ," $" :{" id" :" k0175" }," $$" :[{" #name" :" text" ," _" :" serious adverse event |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
