- Trials with a EudraCT protocol (37)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
37 result(s) found for: rMenB + OMV NZ vaccine.
Displaying page 1 of 2.
EudraCT Number: 2009-018101-52 | Sponsor Protocol Number: V72P13E2 | Start Date*: 2010-05-18 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l | ||
Full Title: 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 Meningoco... | ||
Medical condition: Groups 1a, 1b, 2a and 2b: From the last study visit in V72P13E1 to the start of the study V72P13E2 (Day 1):assessment of immunogenicity or safety Group 3: From birth to the start of the study V7... | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: FI (Completed) CZ (Completed) | ||
Trial results: View results |
EudraCT Number: 2016-003722-16 | Sponsor Protocol Number: 205419 | Start Date*: 2020-05-12 | |||||||||||
Sponsor Name:GlaxoSmithKline Biologicals S.A. | |||||||||||||
Full Title: A Phase IIIB, randomized, observer-blind, multicenter study to assess the safety and immunogenicity of GSK’s meningococcal group B vaccine when administered concomitantly with GSK’s meningococcal M... | |||||||||||||
Medical condition: Healthy volunteers (Active immunization against invasive meningococcal disease caused by 5 different serogroups of N. meningitidis by concomitant administration of meningococcal group B vaccine a... | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-005117-44 | Sponsor Protocol Number: 205240 | Start Date*: 2017-03-10 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of Novartis Meningococcal group B Vaccine When Administered Concomitantly with Novartis MenACWY Conjuga... | ||
Medical condition: Healthy volunteers (Infections, Meningoccal) | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2011-004931-30 | Sponsor Protocol Number: V72P12E2 | Start Date*: 2012-10-10 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | ||
Full Title: A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fift Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who ... | ||
Medical condition: Prevention of meningococcal disease caused by serogroup B Neisseria meningitidis by evaluating the Antibody persistence in 4-year old healthy children who previously received the Novartis meningoco... | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) ES (Completed) IT (Completed) CZ (Completed) | ||
Trial results: View results |
EudraCT Number: 2009-010106-11 | Sponsor Protocol Number: V72P16 | Start Date*: 2009-06-26 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | ||
Full Title: A Phase 2 Observer-Blind Randomized Controlled Multicenter Dose-Ranging and Formulation-Finding Study of a new Novartis Meningococcal B Recombinant Vaccine evaluating the immunogenicity, tolerabili... | ||
Medical condition: The Novartis Meningococcal B Recombinant±OMV NZ vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. This study is aimed at assessing the safe... | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: CZ (Completed) IT (Completed) HU (Completed) | ||
Trial results: View results |
EudraCT Number: 2009-011676-30 | Sponsor Protocol Number: V72P12E1 | Start Date*: 2009-05-12 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | ||
Full Title: A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 1... | ||
Medical condition: Prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B, A fourth (booster) dose of rMenB+OMV NZ is used to evaluate safety tolerability and immunogenicity and exploring t... | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) ES (Completed) DE (Completed) BE (Completed) IT (Completed) CZ (Completed) | ||
Trial results: View results |
EudraCT Number: 2007-007781-38 | Sponsor Protocol Number: V72P13 | Start Date*: 2008-07-02 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l | ||
Full Title: A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administe... | ||
Medical condition: The Novartis Meningococcal B Recombinant + OMV NZ Vaccine is intended for prevention of meninigitidis and/or septicemia caused by N. meningitidis serogroup B. The objective of the Novartis Meningoc... | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: CZ (Completed) FI (Completed) DE (Completed) IT (Completed) AT (Completed) | ||
Trial results: View results |
EudraCT Number: 2006-001522-84 | Sponsor Protocol Number: V72P6 | Start Date*: 2006-08-29 |
Sponsor Name:Novartis Vaccines and Diagnostics Srl. | ||
Full Title: A Phase 2, Open Label, Multi-Center, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Health... | ||
Medical condition: The Novartis Meningococcal B recombinant vaccine is intended for prevention of meningitis and/or septicemia caused by Neisseria meningitidis serogroup B. The objective of the Novartis Meningococcal... | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2009-013054-33 | Sponsor Protocol Number: V72P6E1 | Start Date*: 2009-08-18 |
Sponsor Name:Novartis Vaccines and Diagnostics Srl. | ||
Full Title: A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence compared to Naïve Children and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV N... | ||
Medical condition: The Novartis Meningococcal B recombinant vaccine is intended for prevention of meningitis and/or septicemia caused by Neisseria meningitidis serogroup B. The objective of the Novartis Meningococcal... | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2008-006301-17 | Sponsor Protocol Number: V72P13E1 | Start Date*: 2009-01-20 | |||||||||||
Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L. | |||||||||||||
Full Title: A Phase 3, Open label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Mon... | |||||||||||||
Medical condition: Demonstration of a sufficient immune response following a fourth (booster) dose of rMenB+OMV NZ administered at 12 months of age, either with or without concomitant MMRV vaccination, to toddlers pr... | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) CZ (Completed) FI (Completed) DE (Completed) AT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2006-005589-38 | Sponsor Protocol Number: V72P9 | Start Date*: 2007-01-31 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | ||
Full Title: A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, when Administered to Healthy Infants... | ||
Medical condition: The Novartis Meningococcal B Recombinant +/- OMV Vaccine is intended for prevention of meningitidis and/or septicemia cause by Neisseria menigitidis serogroup B. The objective of the Novartis Menin... | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2014-004476-30 | Sponsor Protocol Number: V72_41 | Start Date*: 2014-10-24 |
Sponsor Name:Novartis Vaccines and Diagnostics SRL | ||
Full Title: A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis rMenB+OMV NZ Vaccine Formulated with Outer Membrane Vesicle (OMV) Manufactu... | ||
Medical condition: Prophylaxis against invasive meningococcal disease | ||
Disease: | ||
Population Age: Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2014-004410-29 | Sponsor Protocol Number: V72P10 | Start Date*: 2014-10-27 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l | ||
Full Title: A Phase 2b/3, Multi-Center, Observer-Blind, Controlled Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine Administered to Healthy Adolescents Aged ... | ||
Medical condition: Prophylaxis against invasive meningococcal disease | ||
Disease: | ||
Population Age: Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2010-023523-23 | Sponsor Protocol Number: V102_03 | Start Date*: 2011-09-30 | |||||||||||
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | |||||||||||||
Full Title: Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents and Young Adults to Evaluate Safety and Immunogenicity of Two Different rMenB with OMV + MenACWY Combination Vacc... | |||||||||||||
Medical condition: Evaluation of two doses of two investigational rMenB(+OMV)+MenACWY combination vaccine formulations given at a 0, 2 month schedule to demonstrate that the safety and immunogenicity of the combinati... | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-001592-30 | Sponsor Protocol Number: V72P12 | Start Date*: 2008-06-11 | |||||||||||
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | |||||||||||||
Full Title: 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... | |||||||||||||
Medical condition: The Novartis Meningococcal B Recombinant + OMV NZ Vaccine is intended for prevention of meningitidis and/or septicemia caused by N.meningitidis serogroup B. The objective of the Novartis Meningococ... | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Completed) BE (Completed) CZ (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-005083-15 | Sponsor Protocol Number: V72_42 | Start Date*: 2014-12-03 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | ||
Full Title: A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 years in Korea. | ||
Medical condition: Prophylaxis Aganist Invasive Group B Meningococcal Disease | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2019-001666-15 | Sponsor Protocol Number: 205416 | Start Date*: 2020-08-14 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: A phase III, randomized, controlled, observer-blind study to demonstrate effectiveness, immunogenicity and safety of GSK's meningococcal Group B and combined ABCWY vaccines when administered to hea... | ||
Medical condition: Healthy volunteers (Active immunization against invasive disease caused by N. meningitidis serogroups A, B, C, W and Y) | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: FI (Completed) CZ (Completed) EE (Completed) Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2009-013075-21 | Sponsor Protocol Number: V72P9E1 | Start Date*: 2009-08-18 |
Sponsor Name:Novartis Vaccines and Diagnostics Srl. | ||
Full Title: A Phase 2, Open-Label, Single-Center, Extension Study Evaluating Antibody Persistence compared to Naïve Children and Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis rMenB±OMV ... | ||
Medical condition: The Novartis Meningococcal B recombinant vaccine is intended for prevention of meningitis and/or septicemia caused by Neisseria meningitidis serogroup B. The objective of the Novartis Meningococcal... | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2017-005128-12 | Sponsor Protocol Number: 208205 | Start Date*: 2018-06-11 | |||||||||||
Sponsor Name:GlaxoSmithKline Biologicals SA | |||||||||||||
Full Title: A Phase II, Randomized, Open-label, Multicenter Study to Assess the Immunogenicity and Safety of GSK Meningococcal MenABCWY Vaccine, and of GSK Meningococcal Group B and MenACWY Conjugate Vaccines ... | |||||||||||||
Medical condition: Primary immunization against Neisseria meningitidis serogroups A, B, C, W-135, and Y. | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: CZ (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-000093-11 | Sponsor Protocol Number: 205218 | Start Date*: 2017-02-08 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Athe Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningo... | ||
Medical condition: Healthy volunteers (Infections, Meningococcal) | ||
Disease: | ||
Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
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