Stan L Block1, Julie Shepard, Hartley Garfield, Fang Xie, Linda Han, Peter M Dull, Igor Smolenov. 1. From the *Kentucky Pediatric and Adult Research, Bardstown, Kentucky; †Ohio Pediatric Research Association, Dayton, Ohio; ‡Resolve Research Solutions, Ontario, Canada; §Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts; and ¶Novartis Pharma BV, Amsterdam, The Netherlands.
Abstract
BACKGROUND: The quadrivalent meningococcal glycoconjugate vaccine MenACWY-CRM is licensed for children from 2 months of age as a 4-dose series. This study assessed the immunogenicity of a 3-dose MenACWY-CRM vaccination series in infants, compared with the 4-dose series, and evaluated the impact of MenACWY-CRM concomitant administration on immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13). METHODS: Overall, 751 healthy infants (age: 55-89 days) were randomized to receive 3 or 4 doses of MenACWY-CRM (2/4/12 or 2/4/6/12 months of age, respectively) with PCV13 + routine vaccinations (ACWY3 and ACWY4 groups, respectively) or PCV13 + routine vaccinations only (routine group). Immunological noninferiority of the 3-dose versus 4-dose MenACWY-CRM vaccination series was evaluated at 13 months of age for serogroups CWY; noninferiority of immune responses to PCV13 serotypes for concomitant administration of MenACWY-CRM and PCV13 was evaluated at 7 and 13 months of age. RESULTS: At 13 months, 88%-100% of subjects in groups ACWY3 and ACWY4 achieved seroprotective bactericidal antibody titers against serogroups ACWY; noninferiority criteria for the 3-dose versus 4-dose MenACWY-CRM vaccination series were met. At 7 months, noninferiority criteria were met for all PCV13 serotypes except for serotypes 3 and 5 (group ACWY3) and 19A (group ACWY4). At 13 months, noninferiority criteria were met for all PCV13 serotypes for both ACWY groups. CONCLUSIONS: After completion of either MenACWY-CRM vaccination series, most subjects achieved seroprotective titers against serogroups ACWY, with the 3-dose series being noninferior to the 4-dose series for serogroups CWY, and no interference with immune responses against PCV13 serotypes was observed (NCT01214837).
RCT Entities:
BACKGROUND: The quadrivalent meningococcal glycoconjugate vaccine MenACWY-CRM is licensed for children from 2 months of age as a 4-dose series. This study assessed the immunogenicity of a 3-dose MenACWY-CRM vaccination series in infants, compared with the 4-dose series, and evaluated the impact of MenACWY-CRM concomitant administration on immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13). METHODS: Overall, 751 healthy infants (age: 55-89 days) were randomized to receive 3 or 4 doses of MenACWY-CRM (2/4/12 or 2/4/6/12 months of age, respectively) with PCV13 + routine vaccinations (ACWY3 and ACWY4 groups, respectively) or PCV13 + routine vaccinations only (routine group). Immunological noninferiority of the 3-dose versus 4-dose MenACWY-CRM vaccination series was evaluated at 13 months of age for serogroups CWY; noninferiority of immune responses to PCV13 serotypes for concomitant administration of MenACWY-CRM and PCV13 was evaluated at 7 and 13 months of age. RESULTS: At 13 months, 88%-100% of subjects in groups ACWY3 and ACWY4 achieved seroprotective bactericidal antibody titers against serogroups ACWY; noninferiority criteria for the 3-dose versus 4-dose MenACWY-CRM vaccination series were met. At 7 months, noninferiority criteria were met for all PCV13 serotypes except for serotypes 3 and 5 (group ACWY3) and 19A (group ACWY4). At 13 months, noninferiority criteria were met for all PCV13 serotypes for both ACWY groups. CONCLUSIONS: After completion of either MenACWY-CRM vaccination series, most subjects achieved seroprotective titers against serogroups ACWY, with the 3-dose series being noninferior to the 4-dose series for serogroups CWY, and no interference with immune responses against PCV13 serotypes was observed (NCT01214837).
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
Authors: Naglaa Mohamed; Yekaterina Timofeyeva; Dorota Jamrozy; Eduardo Rojas; Li Hao; Natalie C Silmon de Monerri; Julio Hawkins; Guy Singh; Bing Cai; Paul Liberator; Shite Sebastian; Robert G K Donald; Ingrid L Scully; C Hal Jones; C Buddy Creech; Isaac Thomsen; Julian Parkhill; Sharon J Peacock; Kathrin U Jansen; Matthew T G Holden; Annaliesa S Anderson Journal: PLoS One Date: 2019-01-14 Impact factor: 3.240