Miguel Tregnaghi1, Pio Lopez2, Daniel Stamboulian3, Gabriela Graña4, Tatjana Odrljin5, Lisa Bedell5, Peter M Dull6. 1. Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina. 2. Centro de Estudios en Infectologia Pediátrica (CEIP), Cali, Colombia. 3. Fundación Centro de Estudios Infectológicos (FUNCEI), French 3085 (C1425AWK), Buenos Aires, Argentina. 4. Novartis Vaccines Clinical Research, Córdoba, Argentina. 5. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA 02139, USA. 6. Novartis Vaccines and Diagnostics, Inc., Cambridge, MA 02139, USA. Electronic address: Peter.Dull@novartis.com.
Abstract
OBJECTIVES: This phase III study assessed the safety and immunogenicity of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, administered with routine vaccines starting at 2 months of age. METHODS:Healthy infants receivedMenACWY-CRM in a two- or three-dose primary infant series plus a single toddler dose. In addition, a two-dose toddler catch-up series was evaluated. Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement (hSBA). Reactogenicity and safety results were collected systematically. RESULTS: After a full infant/toddler series or two-dose toddler catch-up series, MenACWY-CRM elicited immune responses against the four serogroups in 94-100% of subjects. Noninferiority of the two- versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups. Following the three-dose infant primary series, 89-98% of subjects achieved an hSBA ≥ 8 across all serogroups. Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone, except for pertactin after the two-dose infant series. Noninferiority criteria were met for all concomitant antigens after the three-dose infant series. CONCLUSIONS:MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.
RCT Entities:
OBJECTIVES: This phase III study assessed the safety and immunogenicity of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, administered with routine vaccines starting at 2 months of age. METHODS: Healthy infants received MenACWY-CRM in a two- or three-dose primary infant series plus a single toddler dose. In addition, a two-dose toddler catch-up series was evaluated. Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement (hSBA). Reactogenicity and safety results were collected systematically. RESULTS: After a full infant/toddler series or two-dose toddler catch-up series, MenACWY-CRM elicited immune responses against the four serogroups in 94-100% of subjects. Noninferiority of the two- versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups. Following the three-dose infant primary series, 89-98% of subjects achieved an hSBA ≥ 8 across all serogroups. Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone, except for pertactin after the two-dose infant series. Noninferiority criteria were met for all concomitant antigens after the three-dose infant series. CONCLUSIONS: MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.
Authors: Sarah A Mbaeyi; Catherine H Bozio; Jonathan Duffy; Lorry G Rubin; Susan Hariri; David S Stephens; Jessica R MacNeil Journal: MMWR Recomm Rep Date: 2020-09-25