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Clinical trials for Asplenia

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    11 result(s) found for: Asplenia. Displaying page 1 of 1.
    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.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2019-000924-17 Sponsor Protocol Number: P170938J Start Date*: 2019-08-02
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    Full Title: Multicenter, randomized, phase III, trial assessing the immunogenicity and safety of three meningococal B vaccine strategies among patients with asplenia
    Medical condition: asplenic patients at risk for invasive meningococcal disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10041642 Splenectomy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002588-24 Sponsor Protocol Number: B1971060 Start Date*: 2021-06-16
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA® WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE
    Medical condition: prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027276 Meningococcal meningitis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-002410-36 Sponsor Protocol Number: 115524 Start Date*: 2012-07-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled study to evaluate immunogenicity of GSK Biologicals’ MenACWY-TT conjugate vaccine administered intramuscularly to at risk subjects from 1 to less than 18 years and to ...
    Medical condition: Meningococcal infection
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004862 10027275 Meningococcal infection, unspecified LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006495-16 Sponsor Protocol Number: PrEPSo Start Date*: 2022-02-25
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders
    Medical condition: Covid 19 Infection
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084458 COVID-19 prophylaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002888-18 Sponsor Protocol Number: CHAVANET-PHRC-2016 Start Date*: 2018-01-16
    Sponsor Name:CHU Dijon Bourgogne
    Full Title: Adjunction of daptomycin for the treatment of pneumococcal meningitis AddaMAP study
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027253 Meningitis pneumococcal PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001656-29 Sponsor Protocol Number: V110-018 Start Date*: 2015-04-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal D...
    Medical condition: Vaccination against pneumococcal disease caused by the 23 serotypes included in the vaccine
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-006013-34 Sponsor Protocol Number: 115884 Start Date*: 2013-01-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled, multi-centric study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine when administered to childr...
    Medical condition: Active immunization against disease caused by Streptococcus pneumoniae in children 2-17 years of age who are at increased risk of pneumococcal infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    14.1 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    14.1 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    15.1 100000004862 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002822-21 Sponsor Protocol Number: ARCHIE001 Start Date*: 2013-10-10
    Sponsor Name:University of Oxford
    Full Title: The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a double-blind randomised placebo-controlled trial
    Medical condition: Influenza or influenza-like illness
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-016069-27 Sponsor Protocol Number: DORIPED3003 Start Date*: 2010-05-28
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
    Medical condition: Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) LV (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-001663-24 Sponsor Protocol Number: INSIGHT012 Start Date*: 2021-09-20
    Sponsor Name:Office of Sponsored Projects,University of Minnesota
    Full Title: An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Out...
    Medical condition: We are investigating Coronavirus disease 2019 (COVID-19) which is predominantly a respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084460 COVID-19 treatment PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Trial now transitioned) DK (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
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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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