- Trials with a EudraCT protocol (38)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
38 result(s) found for: Bacterial outer membrane.
Displaying page 1 of 2.
EudraCT Number: 2014-002972-95 | Sponsor Protocol Number: V72_74 | Start Date*: 2014-12-09 | |||||||||||
Sponsor Name:Novartis Pharma Services AG | |||||||||||||
Full Title: Phase 3b, Open label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults from 18 to 50 Y... | |||||||||||||
Medical condition: Meningococcal Group B disease. | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: PL (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: 2013-002451-15 | Sponsor Protocol Number: V102_15 | Start Date*: 2014-09-19 | |||||||||||
Sponsor Name:GlaxoSmithKline Biologicals SA | |||||||||||||
Full Title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK... | |||||||||||||
Medical condition: The current study is designed to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those o... | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: FI (Completed) PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-002230-69 | Sponsor Protocol Number: V102_15E1 | Start Date*: 2016-10-31 | |||||||||||
Sponsor Name:GlaxoSmithKline Biologicals S.A. | |||||||||||||
Full Title: A Phase 2b, Open-Label, Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 years After the last Meningococcal Vaccination in Study V102_15 and the Response ... | |||||||||||||
Medical condition: Meningococcal diseases | |||||||||||||
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Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: FI (Completed) PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-005815-25 | Sponsor Protocol Number: V72_59 | Start Date*: 2013-07-09 | |||||||||||
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | |||||||||||||
Full Title: 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 Adu... | |||||||||||||
Medical condition: 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 Adu... | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-001927-74 | Sponsor Protocol Number: SysVac01-C60P2 (PA/2008/2883) | Start Date*: 2009-01-16 |
Sponsor Name:University Hospitals Bristol NHS Foundation Trust | ||
Full Title: A PHASE II, OPEN LABEL, RANDOMISED, TWO CENTRE STUDY TO EVALUATE THE IMPORTANCE OF NATURALLY INDUCED IMMUNE REGULATION ON THE MUCOSAL IMMUNE RESPONSE TO MENINGOCOCCAL SEROGROUP B OUTER MEMBRANE VES... | ||
Medical condition: "Healthy volunteers" In this project we will establish whether naturally induced mucosal CD25+ T regulatory activity in adults and adolescents modulates the mucosal immune response to systemic Me... | ||
Disease: | ||
Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2012-003937-41 | Sponsor Protocol Number: V102_03E1 | Start Date*: 2014-01-17 | |||||||||||
Sponsor Name:GSK Vaccines S.r.l | |||||||||||||
Full Title: Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Follow... | |||||||||||||
Medical condition: This study will evaluate the safety and immunogenicity of a booster dose of MenABCWY vaccine; either MenABCWY+OMV or MenABCWY+1/4OMV, administered to adolescent and young adults who previously rece... | |||||||||||||
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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: 2019-004982-42 | Sponsor Protocol Number: 213171 | Start Date*: 2021-02-08 | |||||||||||
Sponsor Name:GlaxoSmithKline Biologics SA (GSK) | |||||||||||||
Full Title: A phase IIIB, randomized, controlled, observer-blind study to evaluate safety and immunogenicity of GSK’s meningococcal ABCWY vaccine when administered in healthy adolescents and adults, previously... | |||||||||||||
Medical condition: Healthy volunteers (active immunization against invasive disease caused by N. meningitidis serogroups A, B, C, W and Y) | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-000657-30 | Sponsor Protocol Number: V72_28E1 | Start Date*: 2013-05-30 | |||||||||||
Sponsor Name:Novartis Vaccines and Diagnostics s.r.l. | |||||||||||||
Full Title: A Phase IIIB, Open Label, Multi-Center Extension Study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in ... | |||||||||||||
Medical condition: A phase IIIB, Open Label, Multi Center extension study of V72_28 to assess antibody persistence, and the safety and tolerability of a booster dose after the completion of the vaccination course in ... | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Completed) ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-001367-24 | Sponsor Protocol Number: 217043 | Start Date*: 2021-11-16 | |||||||||||
Sponsor Name:GlaxoSmithKline SA | |||||||||||||
Full Title: A Phase II, randomized, partially blinded study to assess the safety, tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administered to healthy infants. | |||||||||||||
Medical condition: Healthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y) | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Temporarily Halted) DE (Trial now transitioned) PL (Trial now transitioned) IT (Completed) FI (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-004741-37 | Sponsor Protocol Number: 212458 | Start Date*: 2021-06-21 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: A Phase I/II, randomised, controlled study to assess the safety, effectiveness and immune response of meningococcal combined ABCWY vaccine when administered to healthy adults (Phase I) and to healt... | ||
Medical condition: Healthy volunteers (Active immunization against IMD caused by Neisseria Meningitidis (N.meningitidis) serogroups A, B, C, W and Y) | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: BE (Completed) FI (Completed) Outside EU/EEA PL (Completed) SE (Completed) | ||
Trial results: (No results available) |
EudraCT Number: 2013-002454-78 | Sponsor Protocol Number: V72_62 | Start Date*: 2014-02-18 | |||||||||||
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l. | |||||||||||||
Full Title: A Phase IIIb, Open Label, Controlled, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of Novartis Meningococcal Group B Vaccine when administered to Immunoco... | |||||||||||||
Medical condition: Meningococcal Group B disease. | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) ES (Completed) PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-003822-42 | Sponsor Protocol Number: B1971048 | Start Date*: 2015-01-30 | |||||||||||
Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017 | |||||||||||||
Full Title: A Phase 4, Single-Arm, Open-Label Study describing the safety and immunogenicity of Bexsero in healthy subjects aged 12 years to <19 years. | |||||||||||||
Medical condition: Test the safety and immunogenicity of Bexsero used as a vaccine for Neisseria meningitidis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-000979-27 | Sponsor Protocol Number: V102_16 | Start Date*: 2015-05-07 |
Sponsor Name:Novartis Vaccines and Diagnostics | ||
Full Title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolesc... | ||
Medical condition: Prophylaxis against invasive disease strains of N. meningitidis serogroup B. | ||
Disease: | ||
Population Age: Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2010-021528-81 | Sponsor Protocol Number: V72_28 | Start Date*: 2011-03-18 | |||||||||||
Sponsor Name:Novartis Vaccines and Diagnostics s.r.l. | |||||||||||||
Full Title: 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 Accordi... | |||||||||||||
Medical condition: 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 seg... | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Completed) HU (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: 2011-003694-29 | Sponsor Protocol Number: V72_37 | Start Date*: 2013-03-26 | |||||||||||
Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L. | |||||||||||||
Full Title: A Phase 3b, Multi-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-risk Adults | |||||||||||||
Medical condition: Healthy volunteers (Meningitis B) | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004992-21 | Sponsor Protocol Number: V72P10E1 | Start Date*: 2014-11-28 |
Sponsor Name:Novartis Vaccines and Diagnostics S.r.l | ||
Full Title: A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10. | ||
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 |
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