کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
6220678 | 1607454 | 2014 | 11 صفحه PDF | دانلود رایگان |
ObjectiveTo evaluate the tolerability and immunogenicity of a booster dose of the quadrivalent meningococcal conjugate vaccine MenACWY-CRM (Menveo, Novartis Vaccines and Diagnostics, Siena, Italy) administered 3 years after primary vaccination of adolescents enrolled in a phase 3 study with either MenACWY-CRM or MenACWY-D (Menactra, Sanofi Pasteur, Swiftwater, Pennsylvania).Study designA total of 730 healthy adolescents participated, including 622 initial study participants who received primary vaccination with MenACWY-CRM (n = 367) or MenACWY-D (n = 255) 3 years previously and 108 age-matched vaccine-naïve controls. A subset of MenACWY-CRM (n = 83) and MenACWY-D (n = 77) recipients were administered a MenACWY-CRM booster dose 3 years postprimary vaccination. Immunogenicity prior to and after the booster dose of MenACWY-CRM was measured by serum bactericidal assay with human complement (hSBA). Local and systemic reactions and adverse events were monitored in subjects receiving the booster dose.ResultsAt 3 years postprimary vaccination, 64%, 82%, and 65% of subjects initially vaccinated with MenACWY-CRM (n = 367) showed hSBA titers â¥8 against serogroups C, W-135, and Y, respectively; this was lower for serogroup A (28%). Significantly more MenACWY-CRM recipients had hSBA titers â¥8 for serogroups W-135 and Y than MenACWY-D recipients (n = 255). A MenACWY-CRM booster dose resulted in 99%-100% of subjects demonstrating hSBA titers â¥8 against all serogroups, irrespective of primary vaccination (MenACWY-CRM, n = 83; MenACWY-D, n = 77). The booster dose was well tolerated without significant adverse events.ConclusionsMenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D.
Journal: The Journal of Pediatrics - Volume 164, Issue 6, June 2014, Pages 1409-1415.e4