A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children aged 2 to 10 Years Estudio fase 3B, abierto y multicéntrico para evaluar la seguridad, tolerabilidad e inmunogenicidad de la vacuna meningocócica recombinante B de Novartis cuando se administra sola a bebés sanos según diferentes programas de inmunización y a niños sanos de entre 2 y 10 años Demostrar una respuesta inmunológica suficiente después de la vacunación con rMenB+OMV NZ, cuando se administra en una serie primaria de dos dosis a bebés sanos a los 31/2 y 5 meses, o a los 6 y 8 mes...

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A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers The primary objective of this phase 3 study is to demonstrate the safety and immune response of MenACWY compared to Menjugate when administered to healthy toddlers at 12 months of age. Subjects will ...

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A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2009-2010, when Administered to Elderly Subjects To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in elderly subjects in compliance with the requirements o...

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A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2011-2012, when Administered to Non-elderly Adult and Elderly Subjects To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-immunization in adult and elderly subjects in compliance with the requ...

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A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine with or without a Second Influenza B Strain in Combination with or without One of Three Different Doses of Adjuvant in Healthy Children, Ages 6 to <36 Months Evaluate safety and tolerability of the study vaccines described below as compared to one and two 0.25 mL IM doses of trivalent inactivated influenza vaccine (TIV) and as compared to a marketed trival...

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Study in adolescent and young adult subjects to evaluate safety and antibody response after the immunization of two vaccine formulations directed against Meningococcal A, B, C, Y and W strains To demonstrate immunologic non-inferiority of two doses of two different formulations of rMenB with OMV + MenACWY to a single dose of Menveo, as measured by the percentage of subjects with hSBA serore...

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A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted with MF59 (FLUAD-H5N1), in Adult and Elderly Subjects Safety Objectives • To assess the safety and tolerability profile of two doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) influenza vaccine (FLUAD-H5N1), each containing 7.5 µg of H5N1 ant...

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Study conducted in immunocompromized patients, 2 to 17 years of age, who are at increased risk of acquiring severe meningococcus diasease because of asplenia or deficiencies of the complement system, in comparison with healthy individuals as controls, in order to evaluate safety, tolerability and antibody response after the administration of two doses of the Novartis investigational vaccine directed mainly against Meningococcus serogroup B. Estudio realizado en pacientes inmunodeprimidos de 2 a 17 años de edad, que presentan un riesgo alto de adquirir enfermedades meningocócicas graves debido a asplenai of deficiencia en el sistema de complemento, en comparación con controles sanos para evaluar la seguridad, tolerabilidad y respuesta inmune tras la administración de dos dosis de la vacuna de investigación de Novartis frente a Meningococo del serogrupo B Immunogenicity Objective ? To evaluate the immunogenicity of two doses of rMenB+OMV NZ in subjects with increased risk of meningococcal disease because of complement deficiency or asplenia and in heal...

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A Phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD versus control vaccines in unprimed healthy subjects aged between 6 and up to 72 months Safety: To demonstrate the safety and tolerability of one or two 0.25mL IM doses of FLUAD in unprimed children aged 6 to <36 months, compared with Agrippal S1 and/or with Influsplit SSW (flu vaccine c...

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A Phase IIIB, observer-blind, randomized, parallel groups, extension study to evaluate the immunogenicity and safety following a single intramuscular dose of FLUAD or Agrippal S1 influenza vaccines in healthy children previously vaccinated in the V70P5 study • To evaluate the immunogenicity of children previously primed with FLUAD® who receive a single IM injection of full dose FLUAD during the extension study • To evaluate the immunogenicity of children...

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