Safety of a quadrivalent meningococcal serogroups A,C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: Results of an open-label,randomized, phase 3b controlled study in healthy infants |
| |
| Authors: | Arturo Abdelnour Peter E Silas Marta Raquel Valdés Lamas Carlos Fernándo Grazioso Aragón Nan-Chang Chiu Cheng-Hsun Chiu Teobaldo Herrera Acuña Tirza De León Castrejón Allen Izu Tatjana Odrljin Igor Smolenov Matthew Hohenboken Peter M Dull |
| |
| Institution: | 1. Instituto de Atención Pediatrica, Apdo 607–1150 La Uruca, San Jose, Costa Rica;2. Wee Care Pediatrics, 2084N 1700W Suite A, Layton, UT, United States;3. Guanchipelin, San Rafael, Escazu, Heredia, Costa Rica;4. Centro de Investigaciones en Pediatría, Guatemala City, Guatemala;5. Department of Pediatrics, Mackay Memorial Hospital, 92, Sec. 2, Zhongshan N. Rd., Zhongshan District, Taipei City 104, Taiwan;6. Department of Pediatrics, Chang Gung Children''s Hospital, Chang Gung University College of Medicine, No.199, Tunghwa Rd., Taipei, Taiwan;g Instituto de Investigación Nutricional, Av. La Molina 1885, Lima 12, Peru;h Hospital Materno Infantil José Domingo de Obaldía, Ciudad de David, Chiriqui, Panama;i Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, MA 02139, United States |
| |
| Abstract: | BackgroundThe highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants.MethodsTwo-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1–7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval CI] of group difference <6%).ResultsA total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI −0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference −0.1% 95% CI −4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups.ConclusionIn a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. |
| |
| Keywords: | AE adverse event DTaP diphtheria tetanus pertussis [vaccine] Hib H influenzae type b [vaccine] IM intramuscular IMD invasive meningococcal disease IPV inactivated polio vaccine SAE serious adverse event |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
