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Clinical trials for Process safety

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   44294   clinical trials with a EudraCT protocol, of which   7351   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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    482 result(s) found for: Process safety. Displaying page 1 of 25.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2004-005023-18 Sponsor Protocol Number: V232-054-00 Start Date*: 2005-06-09
    Sponsor Name:Merck Sharp & Dohme (Sweden) AB
    Full Title: Study in Healthy Young Adults to Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
    Medical condition: Acute hepatitis B without delta-agent and without hepatic coma
    Disease: Version SOC Term Classification Code Term Level
    7.1 10019731 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2005-002578-31 Sponsor Protocol Number: X05-AR21-302 Start Date*: 2005-09-14
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: A controlled, double-blind and randomized study, to compare the immunogenicity and safety of HEXAVAC manufactured by an upgraded process to HEXAVAC manufactured by the current process when given to...
    Medical condition: The vaccine is indicated for primary and booster vaccination of children against six infectious diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis caused by 3 types of poliovirus ...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SK (Ongoing) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002789-12 Sponsor Protocol Number: U05-PnPS-403 Start Date*: 2005-09-28
    Sponsor Name:Sanofi Pasteur MSD S.N.C
    Full Title: A double blind comparative and randomised study in healthy adults of the safety, tolerability, and immunogenicity of PNEUMOVAX®II formulated with either all new process polysaccharides or all curre...
    Medical condition: Prevention of invasive pneumococcal disease (IPD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-003648-46 Sponsor Protocol Number: V121-019-00 Start Date*: 2007-03-12
    Sponsor Name:Merck & Co. Inc.
    Full Title: A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process
    Medical condition: Hepatitis-B infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2006-001638-42 Sponsor Protocol Number: 057-00 Start Date*: 2006-09-22
    Sponsor Name:MSD (Norge) AS
    Full Title: Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and ...
    Medical condition: Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    7.1 10019731 LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2017-001444-35 Sponsor Protocol Number: V210-063 Start Date*: 2017-04-07
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly with M-M-R™ II
    Medical condition: Active immunization for the prevention of varicella in individuals 12 months of age and older
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10069628 Varicella immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003981-15 Sponsor Protocol Number: V232-056 Start Date*: 2016-09-30
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
    Medical condition: Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10019731 Hepatitis B PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003649-18 Sponsor Protocol Number: V232-059-00 Start Date*: 2007-01-12
    Sponsor Name:Merck & Co. Inc.
    Full Title: A Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
    Medical condition: Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019731 Hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001910-27 Sponsor Protocol Number: V210-A03 Start Date*: 2019-07-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    Full Title: A Phase 3, Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Passage Extension 34 (PE34) Process Administered Concomitantl...
    Medical condition: Prevention of varicella in individuals 12 months of age and older
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10069628 Varicella immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001476-63 Sponsor Protocol Number: 2014-001476-63 Start Date*: 2023-05-05
    Sponsor Name:CELLPROTHERA S.A.S
    Full Title: A multicentric controlled phase I / IIb study evaluating the safety and the efficacy of in vitro expanded peripheral blood CD34+ stem cells output by the StemXpand® Automated Process, and injected ...
    Medical condition: Severe acute myocardial Infarction. Indication : Injection of in vitro expanded peripheral blood CD34+ stem cells output by the StempXpand Automated Process, in patients with an acute myocardial in...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003650-20 Sponsor Protocol Number: V232-060-02 Start Date*: 2007-02-19
    Sponsor Name:Merck & Co Inc.,
    Full Title: A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured with a Modified Process
    Medical condition: Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    8.1 10019731 Hepatitis B LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-017781-23 Sponsor Protocol Number: 720903 Start Date*: 2010-01-18
    Sponsor Name:Baxter Innovations GmbH
    Full Title: An Open Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult Population
    Medical condition: To verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season, manufactured according to the ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022000 Influenza LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-004764-39 Sponsor Protocol Number: CTBM100C2303E1 Start Date*: 2009-09-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Comp...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) EE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-002318-22 Sponsor Protocol Number: CTBM100C2303 Start Date*: 2009-09-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a ...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) EE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2009-016734-26 Sponsor Protocol Number: CTBM100C2303E2 Start Date*: 2010-01-08
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who succ...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    12.0 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) LT (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-002048-18 Sponsor Protocol Number: 16/195 Start Date*: 2016-11-21
    Sponsor Name:UNIVERSIDAD REY JUAN CARLOS
    Full Title: Clinical Trial to determine efficacy and safety of healing with platelet-rich plasma, fibrin and leukocytes compared to standard healing with nitrofurazone ointment in subjects with onychocryptosis.
    Medical condition: THE POST-OPERATIVE OF NAIL SURGERY WITH PHENOL 88% TECHNIQUE IN SUBJECTS WITH ONYCOCRYPTOSIS IN BOTH FIRST TOES HEALINGS WITH NITROFURAZONE OINTMENT OR LEUCOYTES, FIBRINE AND PLATELETS PLASMA CLOT.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-001639-23 Sponsor Protocol Number: V232-058 Start Date*: 2006-09-05
    Sponsor Name:Merck SHARP & DOHME DE ESPAÑA
    Full Title: A Study to Assess the Anamnestic Immune Response 4 to 6 Years After a Primary Vaccination Series With HBVAXPRO™ Estudio para evaluar la respuesta inmune anamnésica 4 a 6 años después de una pauta d...
    Medical condition: Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    7.1 10019731 LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-005792-25 Sponsor Protocol Number: R04341 Start Date*: 2017-12-22
    Sponsor Name:Manchester University NHS Foundation Trust
    Full Title: Feasibility study on the effects of L-citrulline on uteroplacental and cardiovascular function in hypertensive pregnant women
    Medical condition: The medical condition that is to be investigated in this study is essential hypertension in pregnant women. In this study it is defined as diastolic BP of ≥90 mmHg (average of two clinic readings) ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10070538 Gestational hypertension PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10014129 Eclampsia PT
    20.0 10047065 - Vascular disorders 10020772 Hypertension PT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005327-63 Sponsor Protocol Number: NN7088-4033 Start Date*: 2016-12-08
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pe...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) DK (Completed) DE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004441-32 Sponsor Protocol Number: MSV-crio Start Date*: 2013-03-06
    Sponsor Name:Fundación Teknon
    Full Title: Pilot clinical trial to determine the feasibility and safety of MSV * cryopreserved in the treatment of gonartrosis. * MSV = mesenchymal progenitor cells of expanded autologous bone marrow with GMP...
    Medical condition: Patients diagnosed with gonarthrosis II, III and IV degrees of Kellgren and Lawrence
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004859 10023476 Knee osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    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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