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Clinical trials for MenACWY-CRM

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44335   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    16 result(s) found for: MenACWY-CRM. Displaying page 1 of 1.
    EudraCT Number: 2014-003514-91 Sponsor Protocol Number: V59P10 Start Date*: 2014-09-30
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with that of a Licensed Meningococcal ACWY P...
    Medical condition: Novartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis A, C, W-135 and Y.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004694-16 Sponsor Protocol Number: V59P21 Start Date*: 2014-11-17
    Sponsor Name:Novartis Vaccines and Diagnostics Inc.
    Full Title: A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of ProQuad™ Vaccine When Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccin...
    Medical condition: Prophylaxis for Neisseria meningitidis serogroup A, C,W-135,and Y.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004973-17 Sponsor Protocol Number: V59_49 Start Date*: 2014-11-18
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A phase 3, multicenter, open-label study to evaluate immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 18 years in Taiwan.
    Medical condition: Prophylaxis against Neisseria meningitidis serogroups A, C, W135 and Y
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001333-17 Sponsor Protocol Number: V59_53 Start Date*: 2011-09-14
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vacci...
    Medical condition: To Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004477-16 Sponsor Protocol Number: V59_43 Start Date*: 2014-11-17
    Sponsor Name:Novartis Healthcare Pvt. Ltd., Vaccines Division
    Full Title: A phase 3, multi-center, open-label study to evaluate immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 75 years of age in India.
    Medical condition: Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004617-82 Sponsor Protocol Number: V59_50 Start Date*: 2014-11-07
    Sponsor Name:Novartis Vaccines and Diagnostics SRL
    Full Title: A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia
    Medical condition: Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003186-25 Sponsor Protocol Number: 205352 Start Date*: 2017-06-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline’s Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Hea...
    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
    EudraCT Number: 2017-000166-30 Sponsor Protocol Number: 205341 Start Date*: 2017-10-04
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GSK Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subj...
    Medical condition: Healthy volunteers (Prevention of invasive meningococcal disease)
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-000475-14 Sponsor Protocol Number: V59_38 Start Date*: 2011-10-25
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in He...
    Medical condition: Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-004421-27 Sponsor Protocol Number: V59_57 Start Date*: 2012-01-20
    Sponsor Name:Novartis Vaccines and Diagnostics s.r.l
    Full Title: A Phase 3b, Randomized, Open-label, Multi-Center Study Assessing Immunogenicity, Safety and 1 Year Persistence of Antibodies after One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine,...
    Medical condition: Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to healthy children 2 to 10 years o...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-004313-13 Sponsor Protocol Number: C3511001 Start Date*: 2020-08-27
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
    Medical condition: Invasive Meningococcal Disease (IMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10076061 Meningococcal immunisation PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) CZ (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-000862-13 Sponsor Protocol Number: V59_67 Start Date*: 2013-07-18
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 2, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals...
    Medical condition: To assess the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-004903-63 Sponsor Protocol Number: V59P13E1 Start Date*: 2014-11-25
    Sponsor Name:Novartis Vaccines and Diagnostics Inc.
    Full Title: An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received MenACWY-CRM Conjugate Vaccine or Menactra
    Medical condition: Novartis Meningococcal ACWY conjugate vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis serogroups A, C, W and Y.
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004446-95 Sponsor Protocol Number: V59P20E1 Start Date*: 2014-11-13
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase IV, open-label, controlled, multi-center study to evaluate the 5-year antibody persistence among children who previously received Novartis MenACWY conjugate vaccine at 2 to 10 years of age ...
    Medical condition: Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004605-33 Sponsor Protocol Number: V59P14 Start Date*: 2014-11-17
    Sponsor Name:Novartis Vaccines & Diagnostics, Inc.
    Full Title: A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered with Routine Infan...
    Medical condition: Meningococcal disease causes high rates of morbidity and mortality even among patients who receive early antibiotic treatment.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004421-17 Sponsor Protocol Number: B1971057 Start Date*: 2020-02-17
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT rLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMA...
    Medical condition: Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W and Y in individuals 10 through 25 years of age.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027249 Meningitis meningococcal PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) FI (Completed) PL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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