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Kusajili – Centralise les essais cliniques mondiaux
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de votre recherche par promoteur : Novartis Vaccines and Diagnostics S.r.l
Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
Title of the trial: A Phase 3, Open-Label, Multi-Center, Extension Study of V72P13E1 to Assess Antibody Persistence at One Year After a Fourth Dose Boost or Two Catch-Up Doses of Novartis Meningococcal B Recombinant Vaccine Administered Starting at 12 Months of Age and to Evaluate the Response to a Third Dose Boost or Two Catch-Up Doses Starting at 24 Months of Age
Immunogenicity :To explore antibody persistence at one year after a booster (fourth) dose of rMenB+OMV NZ, administered at 12 months of age to toddlers enrolled in study V72P13E1 who previously receiv...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
To evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at 40 and 60 months of age in children who were vaccinated with MenACWY- at 2, 4 and 12 months of age, in terms of percentag...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase II, Open Label, Uncontrolled, Multi-Center Study to support annual strain update and to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, (Adjuvanted with MF59C.1) Influenza Vaccine, Formulation 2007-2008, when Administered to Subjects aged 18-64 years affected by chronic diseases
Immunogenicity Objectives To evaluate the antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) at 21 days post-vaccination in at risk adult subjects in com...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine Menjugate® When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age with a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age;
To demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate®...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase II, Observer-Blind, Parallel Groups, Single-Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of FLUAD or Vaxigrip Influenza Vaccines in Healthy Children who Received Either One or the Other Vaccine in the Previous V70P2 Study
·To evaluate the immunogenicity of a single 0.25mL intramuscular (IM) injection of FLUAD or Vaxigrip influenza vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by HI te...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adults Aged 18 to 65 Years inclusive
To assess the immune response, SBA will be performed against the N. meningitidis serogroup B indicator strains H44/76, NZ98/254 and 5/99 at one month after a vaccination course of two doses of rMenB +...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects
Immunogenicity Objective To evaluate the antibody response to each influenza vaccine antigen after vaccination with the aTIV vaccine, as measured by single radial hemolysis (SRH) or hemagglutination ...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase 3, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Toddlers 12 Months of Age, Compared to Single Dose of Meningococcal C Conjugate Vaccine
Immunogenicity objectives 1.To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine given to healthy toddlers, as measured by the percentage of subjects with serum bactericidal as...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered with or without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules
Immunogenicity Objective: To demonstrate a sufficient immune response of rMenB+OMV NZ, when given concomitantly with routine infant vaccines to healthy infants at 2, 4 and 6 and 2, 3 and 4 months of a...
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Femme et Homme Max 99 ans
Novartis Vaccines and Diagnostics S.r.l
MAJ Il y a 5 ans
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2010-2011, 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 non-elderly adult and elderly subjects in compliance w...
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