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Clinical trials for rMenB + OMV vaccine

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    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    39 result(s) found for: rMenB + OMV vaccine. Displaying page 1 of 2.
    1  2  Next»
    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...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027199 Meningitis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA IT (Completed)
    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: 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: 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: 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: 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: 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: 2014-005160-15 Sponsor Protocol Number: V102_02 Start Date*: 2014-12-03
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: Phase 2, Observer Blinded, Controlled, Randomized Multi-Center Study in Adolescents, to Evaluate Safety, Tolerability and Immunogenicity of Four Different rMenB plus MenACWY Formulations
    Medical condition: Prophylaxis against Neisseria meningitidis serogroup A, B, C, W-135 and Y diseases.
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 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...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027249 Meningitis meningococcal LLT
    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: 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...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (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: 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...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027276 Meningococcal meningitis LLT
    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: 2014-005014-36 Sponsor Protocol Number: V102_02E1 Start Date*: 2014-11-25
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + Me...
    Medical condition: To prevent Meningococcal meningitis and sepsis caused by Neisseria meningitidis.
    Disease:
    Population Age: 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: 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: 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
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