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Clinical trials for Harmonization

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    43 result(s) found for: Harmonization. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2013-000881-12 Sponsor Protocol Number: M13-998 Start Date*: 2013-07-11
    Sponsor Name:Abbott Biologicals B.V
    Full Title: Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2013/2014. An Open-Label, Baseline- Controlled Study in Two Age Gro...
    Medical condition: Prophylaxis of Influenza
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004862 10022005 Influenza viral infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001032-57 Sponsor Protocol Number: M13-567 Start Date*: 2012-06-26
    Sponsor Name:Abbott Biologicals B.V.
    Full Title: Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Northern Hemisphere Season 2012/2013. An Open-Label, Baseline- Controlled Study in Two Age ...
    Medical condition: Prophylaxis of Influenza
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022005 Influenza viral infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018603-29 Sponsor Protocol Number: V70_25S Start Date*: 2010-05-17
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2010-201...
    Medical condition: Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059430 LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-001300-37 Sponsor Protocol Number: S201.3.125 Start Date*: 2006-07-11
    Sponsor Name:Solvay Pharmaceuticals B.V.
    Full Title: Immunogenicity and reactogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2006/2007. An open, baseline-controlled study in two groups of healthy subjects: adult subjects...
    Medical condition: Prophylaxis of influenza, especially in those who run an increased risk of associated complications.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002254-20 Sponsor Protocol Number: 1297.9 Start Date*: 2017-08-04
    Sponsor Name:Boehringer Ingelheim International GmbH
    Full Title: VOLTAIRE-X: Pharmacokinetics, safety, immunogenicity and efficacy of BI 695501 versus Humira® in patients with moderate to severe chronic plaque psoriasis: a randomized, double-blind, parallel-arm,...
    Medical condition: moderate to severe chronic plaque psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-021841-38 Sponsor Protocol Number: V70_32S Start Date*: 2011-02-24
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine (Fluad), Formulation 2011...
    Medical condition: A single 0.5 mL dose administered by intramuscular injection into the deltoid muscle of Fluad is recommended for active immunisation against influenza in the elderly (65 years of age and over), esp...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000341-11 Sponsor Protocol Number: S206.3.010 Start Date*: 2005-06-06
    Sponsor Name:Solvay Pharmaceuticqals B.V.
    Full Title: Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2005/2006. An open, baseline controlled study in two groups of healthy subjects: adult subject...
    Medical condition: Prophylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-003791-38 Sponsor Protocol Number: S206.3.011 Start Date*: 2008-08-23
    Sponsor Name:Solvay Pharmaceuticals B.V.
    Full Title: Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2005/2006. An open, baseline controlled study in two groups of healthy subjects: adult subject...
    Medical condition: Prophylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-004087-40 Sponsor Protocol Number: PR-CS011 Start Date*: 2008-10-06
    Sponsor Name:Prospect Therapeutics, Inc
    Full Title: A Phase 2 Study of GCS-100 in Combination with Chemo-immunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Medical condition: Relapsed or refractory diffuse large B-cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012822 Diffuse large B-cell lymphoma refractory LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2010-022882-80 Sponsor Protocol Number: 2010.621 Start Date*: 2010-09-17
    Sponsor Name:Hospices Civils de Lyon
    Full Title: EXPAND ID. Analyse de la réponse immunitaire à la vaccination anti-grippe chez les sujets âgés de 65 ans et plus.
    Medical condition: Sujets de 65 ans et plus, ayant été vaccinés contre la grippe saisonnière
    Disease: Version SOC Term Classification Code Term Level
    12.1 10014348 Elderly LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-001301-28 Sponsor Protocol Number: S206.3.012 Start Date*: 2006-05-19
    Sponsor Name:Solvay Pharmaceuticals B.V.
    Full Title: Immunogenicity and reactogenicity of the trivalent virosomal influenza vaccine Invivac® for the season 2006/2007. An open, baseline-controlled study in two groups of healthy subjects: adult subject...
    Medical condition: Prophylaxis of influenza in adults and the elderly, especially in those who run an increased risk of associated complications.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-000085-38 Sponsor Protocol Number: V70_39S Start Date*: 2012-03-08
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2012-201...
    Medical condition: Clinical Trial on healthy volunteers (Active immunisation against influenza in the elderly (65 years of age and over), especially for those with an increased risk of associated complications (i.e. ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-006831-10 Sponsor Protocol Number: 1199.15 Start Date*: Information not available in EudraCT
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Multicenter, randomised, double-blind Phase III trial to investigate the efficacy and safety of BIBF 1120 in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and pac...
    Medical condition: Advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026469 Malignant neoplasm of specified parts of peritoneum LLT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026340 Malignant neoplasm of peritoneum, unspecified LLT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016180 Fallopian tube cancer PT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) FR (Completed) SE (Completed) BE (Completed) PT (Completed) SK (Completed) DK (Completed) AT (Completed) NL (Completed) FI (Completed) PL (Completed) IT (Completed) GR (Completed) CZ (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002122-67 Sponsor Protocol Number: 1211 Start Date*: 2013-12-05
    Sponsor Name:EORTC
    Full Title: Phase II randomized comparative trial of TAK-700 (Orteronel) versus bicalutamide in metastatic prostate cancer patients failing 1st line treatment with LHRH analogs or surgical castration.
    Medical condition: metastatic prostate cancer patients failing 1st line treatment with LHRH analogs or surgical castration
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-000063-24 Sponsor Protocol Number: V71_32S Start Date*: 2012-03-08
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety & Immunogenicity of AGRIPPAL S1 Vaccine, Formulation 2012-2013, in Non-elderly Adult and Elderly Subjects
    Medical condition: Clinical trial on healthy volunteers: prophylaxis of influenza, especially in subjects with a higher risk of flu associated complications.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-005985-35 Sponsor Protocol Number: 1206.15 Start Date*: 2006-08-29
    Sponsor Name:Boehringer Ingelheim
    Full Title: A 24 week, MRI based, double-blind, randomised, placebo-controlled, modified dose-escalation trial to evaluate the safety, efficacy and pharmacokinetics of BIRT 2584 XX tablets at doses of 100, 300...
    Medical condition: Relapsing forms of Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019802-17 Sponsor Protocol Number: 205.438 Start Date*: 2010-09-13
    Sponsor Name:Boehringer Ingelheim France
    Full Title: A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 μg administered once daily via the Respimat® device in pati...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) FR (Completed) SK (Completed) DE (Completed) GB (Completed) BE (Completed) CZ (Completed) IT (Completed) AT (Completed) IE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-005215-98 Sponsor Protocol Number: IUWP2005.01 Start Date*: 2007-03-12
    Sponsor Name:Sanquin Plasma Products
    Full Title: Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.
    Medical condition: Established diagnosis of IgG subclass deficiency, and/or (selective) antipolysaccharide antibody deficiency.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10021275 IgG subclass deficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-006271-18 Sponsor Protocol Number: V78_10S Start Date*: 2012-07-23
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3 Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Fluvirin®), Flirmulation 2012/2013, when Administe...
    Medical condition: Prophylaxis of influenza
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024400-98 Sponsor Protocol Number: V71_27S Start Date*: 2011-02-24
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2011-2012, when Administer...
    Medical condition: Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risk and ...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (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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