Safety and Immunogenicity of the Quadrivalent Meningococcal Serogroups A, C, W and Y Tetanus Toxoid Conjugate Vaccine Coadministered With Routine Childhood Vaccines in European Infants An Open, Randomized Trial
| Autor: | Gerhard Bleckmann, Marie Van der Wielen, Maria Méndez, Fernando Centeno Malfaz, María del Carmen Otero Reigada, Mariano Miranda, Thomas Fischbach, Jose Manuel Merino Arribas, Christoph Wittermann, Michael Horn, Miguel Angel Garcia Cabezas, Yaela Baine, Xavier Maria Perez Porcuna, Devayani Kolhe, Josep Mares Bermudez, Alfonso Carmona Martinez |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Pediatrics medicine.medical_specialty 030106 microbiology Immunization Secondary Meningococcal Vaccines bactericidal activity complex mixtures law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Conjugate vaccine law medicine booster Humans 030212 general & internal medicine Tetanus business.industry Immunogenicity Vaccination Toxoid Infant quadrivalent meningococcal conjugate vaccine coadministration medicine.disease Antibodies Bacterial infant Europe Meningococcal Infections Infectious Diseases Immunization Pediatrics Perinatology and Child Health business Meningitis |
| Zdroj: | The Pediatric infectious disease journal r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe instname |
| ISSN: | 0891-3668 |
| Popis: | Background: This was the first study evaluating the immunogenicity and safety of the quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) coadministered with routine childhood vaccines in young infants. Methods: In this open, randomized, controlled, phase III study (NCT01144663), 2095 infants (ages 6-12 weeks) were randomized (1: 1: 1: 1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age, or MenACWY-TT, MenC-cross-reactive material (CRM197) or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immune responses were measured by serum bactericidal activity assays using rabbit (rSBA) and human (hSBA) complement. Solicited and unsolicited symptoms were recorded during 8 and 31 days post-vaccination, respectively, and serious adverse events throughout the study. Results: Noninferiority of immune responses to MenC induced by 2 or 3 doses of MenACWY-TT versus 2 doses of MenC-TT or MenC-CRM197 was demonstrated. Predefined criteria for the immunogenicity of MenACWY-TT to MenA, MenW and MenY were met. One month after 2 or 3 primary MenACWY-TT doses, >= 93.1% and >= 88.5% of infants had rSBA and hSBA titers >= 1: 8 for all serogroups. The robust increases in rSBA and hSBA titers observed for all vaccine serogroups postbooster vaccination suggested that MenACWY-TT induced immune memory. MenACWY-TT coadministered with childhood vaccines had a clinically acceptable safety profile. Conclusions: This study supports the coadministration of MenACWY-TT with routine childhood vaccines as 2 or 3 primary doses during infancy followed by a booster dose in the second year of life. |
| Databáze: | OpenAIRE |
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