Calendario›SNY›Meningococcal Polysaccharide
Meningococcal Polysaccharide
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
Ensayo de Sanofi en Meningitis · Meningococcal Meningitis · Meningococcal Infections (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 1.715
- Centros
- 36
- Fin del objetivo primario
- oct 2015
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en jul 2014.
Qué mide
Percentage of Participants Achieving Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine (Day 30 (post-vaccination)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This study also evaluated the immunogenicity and safety of MenACYW Conjugate vaccine when given alone compared to when given concomitantly with tetanus, diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine. Primary objective: * To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was given alone. Secondary objective: * To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines, compared to those when it was given alone. * To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine was given with HPV vaccine only. * To evaluate the antibody responses to the antigens present in HPV vaccine after the 3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine is given with Tdap vaccine only. Observational objective: * To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV vaccines.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02199691), actualizada en mar 2022.