Abstract BACKGROUND: Given the broad age range across which the quadrivalent meningococcal conjugate vaccine MenACWY-CRM is used, co-administration with routine vaccines should be evaluated across age groups for possible immunologic interference and impact on vaccine reactogenicity and safety. METHODS: We summarize data from a large population of infants, adolescents, and international travellers from 10 phase 3/4 clinical studies to evaluate co-administration of MenACWY-CRM with commonly administered vaccines. Noninferiority analyses of immune responses were performed across studies and age groups for each vaccine. Reactogenicity and safety were also assessed. RESULTS: In infants, MenACWY-CRM co-administered with routine vaccines did not reduce immune responses to diphtheria, tetanus, poliovirus, hepatitis B, Haemophilus influenzae type b, pneumococcal conjugate (PCV), measles-mumps-rubella, varicella or pertussis antigens. Noninferiority criteria were not met for some PCV serotypes at 7 months of age, but no consistent trends were observed. In adolescents, co-administration did not reduce immune responses to tetanus, diphtheria and human papilloma virus vaccine antigens. Noninferiority criteria for pertussis antigens were not uniformly met in infant and adolescent studies, although the clinical relevance is unclear. In adults, co-administration did not reduce immune responses to hepatitis A/B, typhoid fever, yellow fever, Japanese encephalitis and rabies antigens. Immune responses to MenACWY-CRM were not impacted by co-administration of commonly administered vaccines. Co-administration did not increase frequencies of post-vaccination adverse events in any age group. CONCLUSIONS: With no clinically relevant vaccine interactions or impact on vaccine reactogenicity or safety, these results support the co-administration of MenACWY-CRM with routine vaccines in all age groups.
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|Titolo:||Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine and Commonly Administered Vaccines after Co-administration.|
|Data di pubblicazione:||2016|
|Appare nelle tipologie:||01.01 - Articolo su rivista|