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Clinical trials for Recombinant DNA

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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    286 result(s) found for: Recombinant DNA. Displaying page 1 of 15.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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 (Completed) SE (Completed)
    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 (Completed) FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-022726-33 Sponsor Protocol Number: 251001 Start Date*: 2011-03-24
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level 1- 2%) Hemo...
    Medical condition: Previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level 1- 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BG (Completed) CZ (Completed) GB (Completed) DE (Prematurely Ended) SE (Completed) PL (Completed) ES (Completed) IT (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002451-15 Sponsor Protocol Number: V102_15 Start Date*: 2014-09-19
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK...
    Medical condition: The current study is designed to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those o...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-002230-69 Sponsor Protocol Number: V102_15E1 Start Date*: 2016-10-31
    Sponsor Name:GlaxoSmithKline Biologicals S.A.
    Full Title: A Phase 2b, Open-Label, Multi-Center Study Assessing the Immunological Persistence of Antibodies at Approximately 2 years After the last Meningococcal Vaccination in Study V102_15 and the Response ...
    Medical condition: Meningococcal diseases
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000979-27 Sponsor Protocol Number: V102_16 Start Date*: 2015-05-07
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolesc...
    Medical condition: Prophylaxis against invasive disease strains of N. meningitidis serogroup B.
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-005128-12 Sponsor Protocol Number: 208205 Start Date*: 2018-06-11
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase II, Randomized, Open-label, Multicenter Study to Assess the Immunogenicity and Safety of GSK Meningococcal MenABCWY Vaccine, and of GSK Meningococcal Group B and MenACWY Conjugate Vaccines ...
    Medical condition: Primary immunization against Neisseria meningitidis serogroups A, B, C, W-135, and Y.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-002437-19 Sponsor Protocol Number: 251101 Start Date*: 2011-10-28
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX326 (RECOMBINANT FACTOR IX): A PHASE 2/3 PROSPECTIVE, UNCONTROLLED, MULTICENTER STUDY EVALUATING PHARMACOKINETICS, EFFICACY, SAFETY, AND IMMUNOGENICITY IN PREVIOUSLY TREATED PEDIATRIC PATIENTS W...
    Medical condition: Pediatric previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-005815-25 Sponsor Protocol Number: V72_59 Start Date*: 2013-07-09
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adu...
    Medical condition: A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-Risk Adu...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-019374-32 Sponsor Protocol Number: CP-4-003 Start Date*: 2010-07-15
    Sponsor Name:ModigeneTech Ltd.
    Full Title: A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA)
    Medical condition: Growth Hormone Deficiency
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056438 Growth hormone deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) SI (Completed) CZ (Completed) DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002972-95 Sponsor Protocol Number: V72_74 Start Date*: 2014-12-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase 3b, Open label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults from 18 to 50 Y...
    Medical condition: Meningococcal Group B disease.
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-003937-41 Sponsor Protocol Number: V102_03E1 Start Date*: 2014-01-17
    Sponsor Name:GSK Vaccines S.r.l
    Full Title: Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Follow...
    Medical condition: This study will evaluate the safety and immunogenicity of a booster dose of MenABCWY vaccine; either MenABCWY+OMV or MenABCWY+1/4OMV, administered to adolescent and young adults who previously rece...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-020060-38 Sponsor Protocol Number: CACZ885H2357E2 Start Date*: 2010-08-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label extension study of CACZ885H2357E1 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated...
    Medical condition: Treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018627 Gout LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-003070-31 Sponsor Protocol Number: VAN00002 Start Date*: 2022-01-24
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants
    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: Infants and toddlers, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-000413-39 Sponsor Protocol Number: 251002 Start Date*: 2011-10-06
    Sponsor Name:Baxter Innovations GmbH
    Full Title: BAX 326 (recombinant factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX level < 1%) or Moderately Severe (FIX level ...
    Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B undergoing surgical or other invasive procedures
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) SE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001923-30 Sponsor Protocol Number: TN-20 Start Date*: 2016-09-26
    Sponsor Name:TRIALNET COORDINATING CENTER AT THE UNIVERSITY OF SOUTH FLORIDA
    Full Title: Exploring Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066284 Diabetes prophylaxis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004461-41 Sponsor Protocol Number: MET59 Start Date*: 2020-02-14
    Sponsor Name:Sanofi Pasteur Inc
    Full Title: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
    Medical condition: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y and W)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-000453-37 Sponsor Protocol Number: 3179/AO/14 Start Date*: 2014-12-16
    Sponsor Name:Azienda Ospedaliera di Padova
    Full Title: Sequential treatment with nucleotide analogue and peg-interferon in patients with HBV-related chronic hepatitis.
    Medical condition: Hepatitis B virus (HBV)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001666-15 Sponsor Protocol Number: 205416 Start Date*: 2020-08-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, controlled, observer-blind study to demonstrate effectiveness, immunogenicity and safety of GSK's meningococcal Group B and combined ABCWY vaccines when administered to hea...
    Medical condition: Healthy volunteers (Active immunization against invasive disease caused by N. meningitidis serogroups A, B, C, W and Y)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) CZ (Completed) EE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000924-13 Sponsor Protocol Number: VAN00010 Start Date*: 2023-12-21
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity study to assess Pentavalent Meningococcal ABCYW Vaccine formulations in Adults (18 to 25 years of age) and Adolescents (10 to 17 yea...
    Medical condition: Bacterial infections and mycoses
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
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