Novartis: Meningitis, Meningococcal trials

The registry lists 32 Meningitis, Meningococcal studies with Novartis as lead sponsor. 0 are open to participants now and 28 have results posted.

Phase 2 10Phase 3 21Phase 4 1No phase 2(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.CompletedNCT02305446Phase 3Results posted
• Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28CompletedNCT01894919Phase 3Results posted
• Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1CompletedNCT01717638Phase 3Results posted
• A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk AdultsCompletedNCT01478347Phase 3Results posted
• A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in AdultsCompletedNCT01466387Phase 3Results posted
• Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate VaccineCompletedNCT01453348Phase 3Results posted
• Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy ToddlersCompletedNCT01434680Phase 2Results posted
• A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in AdolescentsCompletedNCT01424644Phase 4Results posted
• Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 YearsCompletedNCT01423084Phase 3Results posted
• Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study VaccinesCompletedNCT01367158Phase 2Results posted
• 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 YearsCompletedNCT01339923Phase 3Results posted
• A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in KoreaCompletedNCT01274897Phase 3Results posted
• Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of LifeCompletedNCT01214837Phase 3Results posted
• Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10CompletedNCT01148524Phase 2/3Results posted
• Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate VaccineCompletedNCT01148017Phase 3Results posted
• A Study to Evaluate the Persistence and Immune Response to a Booster Dose of MenACWYCompletedNCT01018732Phase 2Results posted
• Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12CompletedNCT00944034Phase 2/3Results posted
• Safety and Immunogenicity in Dose-Ranging and Formulation-Finding Meningococcal B (MenB) Vaccine Study in 2-month-old InfantsCompletedNCT00937521Phase 2Results posted
• Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate VaccineCompletedNCT00856297Phase 3Results posted
• Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and ToddlersCompletedNCT00667602Phase 3Results posted
• Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy InfantsCompletedNCT00657709Phase 3Results posted
• A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In AdolescentsCompletedNCT00518180Phase 3Results posted
• A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In InfantsCompletedNCT00474526Phase 3Results posted
• A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy AdultsCompletedNCT00474487Phase 3Results posted
• A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and AdultsCompletedNCT00450437Phase 3Results posted
• Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 YearsCompletedNCT00329901Phase 3Results posted
• Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)CompletedNCT00310856Phase 2Results posted
• Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.CompletedNCT00310817Phase 2Results posted
• Safety of MenACWY-CRM Vaccination in AdolescentsCompletedNCT01452464
• Safety Surveillance of MenACWY-CRM Vaccine in ChildrenCompletedNCT01452438
• Immunogenicity and Safety of Different rMenB Plus MenACWY Formulations in AdolescentsCompletedNCT01210885Phase 2
• Study of the Safety and Immune Response of Two Serogroup B Meningococcal Vaccines Administered to Healthy AdolescentsCompletedNCT00297817Phase 2