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Clinical trials for Biological Indicator

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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    22 result(s) found for: Biological Indicator. Displaying page 1 of 2.
    1  2  Next»
    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: 2014-005568-14 Sponsor Protocol Number: V72_60 Start Date*: 2015-06-08
    Sponsor Name:Novartis Pharma Services A.G.
    Full Title: A Phase 3, Open Label, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Concomitantly With Rout...
    Medical condition: Prophylaxis of meningococcal meningitiditis caused by Neisseria meningitidis bacterium, serogroup B
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000764-58 Sponsor Protocol Number: 219967 Start Date*: 2023-10-03
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 4, single-arm, open-label, multi-center study to assess the immune response and safety of the meningococcal Group B vaccine MenB+OMV NZ when administered to healthy infants from 2 months of...
    Medical condition: Healthy volunteers (active immunization of infants against invasive meningococcal disease (IMD) due to N. meningitidis serogroup B infection).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    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: 2011-003943-23 Sponsor Protocol Number: SP848-AK-1101 Start Date*: 2012-03-29
    Sponsor Name:Spirig Pharma AG
    Full Title: Prospective, randomized, partly blinded, in part placebo-controlled, multicenter, dose-finding trial exploring safety, tolerability and efficacy of a topical resiquimod gel in patients with multipl...
    Medical condition: Actinic Keratosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001670-33 Sponsor Protocol Number: 215344 Start Date*: 2022-02-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIb, Randomized, Observer-Blind study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
    Medical condition: Healthy volunteers (Active immunization against IMD caused by N.meningitidis serogroups A, B, C, W and Y)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027249 Meningitis meningococcal PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    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)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027249 Meningitis meningococcal PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) DE (Trial now transitioned) PL (Trial now transitioned) IT (Temporarily Halted) FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-000447-27 Sponsor Protocol Number: USKH_VL1 Start Date*: 2012-07-25
    Sponsor Name:Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Full Title: Open Label Study for the Functional Characterization of Drug Metabolism and Transport in patients before routine visceral surgery
    Medical condition: Pharmacokinetic trial in patients, with a good general condition before standard abdominal surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2015-003042-47 Sponsor Protocol Number: InsulaTOP Start Date*: 2015-12-16
    Sponsor Name:Centre Hospitalier Henri Laborit
    Full Title: Psycho-biological substrates of therapeutic benefit of thermal cure on Generalized Anxiety Disorders
    Medical condition: Generalised Anxiety Disorders
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10018105 Generalized anxiety disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    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 (Ongoing) SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005401-28 Sponsor Protocol Number: AOI2021ME_PICKERING Start Date*: 2022-01-26
    Sponsor Name:University Hospital of Clermont-Ferrand
    Full Title: Effects of the combination of magnesium bisphosphonates versus bisphosphonates alone on bone remodeling: Randomized pilot clinical trial
    Medical condition: postmenopausal osteoporosis
    Disease:
    Population Age: Elderly Gender: Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-000093-11 Sponsor Protocol Number: 205218 Start Date*: 2017-02-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 3b, Open Label, Controlled, Multi-Center, Extension Study to Athe Persistence of Bactericidal Activity at 4 to 7.5 Years After Two Dose Primary Series of GlaxoSmithKline Biologicals Meningo...
    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: 2018-003218-42 Sponsor Protocol Number: RC18_0287 Start Date*: 2019-01-16
    Sponsor Name:CHU de Nantes
    Full Title: Phase 2 study evaluating MEchanisms of resistance on tumor tissue and Liquid biopsy in patients with EGFR mutated nonpretreated advanced Lung cancer Receiving OSimErtinib until and beyond radiologi...
    Medical condition: Locally advanced or metastatic Non-small-cell lung carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    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 ...
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003056-21 Sponsor Protocol Number: WIRE Start Date*: 2020-02-07
    Sponsor Name:Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    Full Title: Window-of-opportunity clinical trials platform for evaluation of novel treatment strategies in renal cell cancer.
    Medical condition: Surgically resectable renal cell cancer (Stage M0/M1)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038389 Renal cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038389 Renal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-000518-34 Sponsor Protocol Number: 0107 Start Date*: 2011-10-25
    Sponsor Name:Rikshospitalet
    Full Title: Effect of beta blockade on left ventricular remodeling and function in aortic regurgitation
    Medical condition: The aim of the present study is therefore to assess the effect of a 6 month treatment with beta-blocker on left ventricular remodeling and function in patients with asymptomatic moderate to severe ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004849 10002904 Aortic regurgitation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000276-38 Sponsor Protocol Number: MIBIOTIMI Start Date*: 2021-07-06
    Sponsor Name:Álvaro Ruibal Morell
    Full Title: Tumour heterogeneity studies based on dedicated breast PET using proliferation radiotracers: early detection of the treatment response
    Medical condition: Breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000193-35 Sponsor Protocol Number: MONAVI-1 Start Date*: 2015-10-01
    Sponsor Name:Centre François Baclesse
    Full Title: A phase II study of ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer
    Medical condition: Platinum-resistant or refractory ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-002766-31 Sponsor Protocol Number: 1200.277 Start Date*: 2018-11-23
    Sponsor Name:UCL
    Full Title: A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first line or later line treatment in advanced chordoma
    Medical condition: Chordoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008747 Chordoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003407-38 Sponsor Protocol Number: 8669-062 Start Date*: 2012-01-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Paediatric Patients with Advanced Solid Tumours
    Medical condition: Advanced solid tumours including lymphoma and tumours of the central nervous system.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065143 Malignant solid tumour LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) FR (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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