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J Pediatr ; 164(6): 1409-15.e4, 2014 Jun.
Article de Anglais | MEDLINE | ID: mdl-24657122

RÉSUMÉ

OBJECTIVE: To 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 DESIGN: A 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. RESULTS: At 3 years postprimary vaccination, 64%, 82%, and 65% of subjects initially vaccinated with MenACWY-CRM (n = 367) showed hSBA titers ≥8 against serogroups C, W-135, and Y, respectively; this was lower for serogroup A (28%). Significantly more MenACWY-CRM recipients had hSBA titers ≥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 ≥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. CONCLUSIONS: MenACWY-CRM can be used to boost adolescents who have received a primary vaccination with either MenACWY-CRM or MenACWY-D.


Sujet(s)
Anticorps antibactériens/immunologie , Rappel de vaccin/méthodes , Méningite à méningocoques/prévention et contrôle , Vaccins antiméningococciques/administration et posologie , Adolescent , Anticorps antibactériens/sang , Relation dose-effet des médicaments , Femelle , Études de suivi , Humains , Mâle , Méningite à méningocoques/immunologie , Infections à méningocoques/immunologie , Infections à méningocoques/prévention et contrôle , Vaccins antiméningococciques/effets indésirables , Neisseria meningitidis/immunologie , Sécurité des patients , Appréciation des risques , Facteurs temps , Résultat thérapeutique , Vaccination/méthodes , Vaccins conjugués/administration et posologie , Vaccins conjugués/effets indésirables
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