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Clinical trials for Tuberculosis vaccine

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   44339   clinical trials with a EudraCT protocol, of which   7369   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 ).  
     
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    18 result(s) found for: Tuberculosis vaccine. Displaying page 1 of 1.
    EudraCT Number: 2021-003301-22 Sponsor Protocol Number: AC-R6 Start Date*: 2021-10-05
    Sponsor Name:Archivel Farma S.L.
    Full Title: A phase IIB study to explore the efficacy and safety of the concomitant administration of RUTI® immunotherapy with the standard treatment in patients with TB (CONSTAN)
    Medical condition: Pulmonary Tuberculosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10044755 Tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001820-36 Sponsor Protocol Number: 114886 Start Date*: 2012-10-15
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II observer blind, randomised, controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccine GSK 692342 when administered to ...
    Medical condition: Vaccination against tuberculosis (TB) in adults aged 18 to 59 years with TB disease.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10045023 Tuberculosis prophylaxis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: EE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000850-36 Sponsor Protocol Number: 201600136 Start Date*: 2017-05-01
    Sponsor Name:Archivel Farma S.L.
    Full Title: Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculos...
    Medical condition: The medical condition to be investigated is culture-confirmed Multidrug-resistant tuberculosis, i.e. tuberculosis resistant to the two first-line drugs Rifampicin and Isoniazid
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002541-37 Sponsor Protocol Number: 116777 Start Date*: 2012-08-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, open label, mono-centric study to evaluate the kinetics of mRNA expression after two doses of GSK Biologicals’ candidate tuberculosis (TB) vaccine GSK 692342 in healthy BCG-primed, HIV-...
    Medical condition: Healthy volunteers (Prevention of tuberculosis [TB] disease in children, adolescents and adults)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000736-10 Sponsor Protocol Number: BCG-RIS-01 Start Date*: 2019-01-24
    Sponsor Name:FONDAZIONE ITALIANA SCLEROSI MULTIPLA ONLUS
    Full Title: “Bacille Calmette-Guérin (BCG) vaccine In Radiologically Isolated Syndrome (Ris)”
    Medical condition: Radiologically Isolated Syndrome (Ris)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10079292 Radiologically isolated syndrome PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-004497-24 Sponsor Protocol Number: 106227, 106228, 108736, 108738 Start Date*: 2006-10-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Observer-blinded, randomised, controlled, phase I/II study, to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccines M72/AS01B and M72/AS02A wh...
    Medical condition: Vaccination against tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004380-44 Sponsor Protocol Number: 112899 Start Date*: 2015-05-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, open-label, randomised controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine (M72/AS01E) when administered i...
    Medical condition: Healthy volunteers (evaluation of safety and reactogenicity of TB vaccine when administered in healthy infants)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-000358-13 Sponsor Protocol Number: A3921187 Start Date*: 2014-12-04
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATO...
    Medical condition: Moderately to severely active Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) EE (Completed) LT (Completed) LV (Completed) GB (Completed) ES (Completed) PL (Completed) BG (Completed) RO (Completed) DE (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2020-002111-22 Sponsor Protocol Number: BCG/COVID-19/UR/04/2020 Start Date*: 2020-06-26
    Sponsor Name:University of Rzeszów
    Full Title: A multi-centre, randomised, double-blind, placebo-controlled phase III study assessing the impact of BCG vaccination on the incidence and course of SARS-CoV-2 infection among healthcare workers in ...
    Medical condition: not applicable
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000182-33 Sponsor Protocol Number: 76421 Start Date*: 2021-03-25
    Sponsor Name:Radboudumc
    Full Title: Effect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccine in health care workers
    Medical condition: Immunogenicity of the mRNA BNT162b2 COVID-19 vaccine.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-018279-99 Sponsor Protocol Number: HUM07-066 Start Date*: 2010-05-05
    Sponsor Name:Faculty of Medicine, Otto-von-Guericke-University Magdeburg
    Full Title: Skin Topoproteome under Adalimumab (Humira®) Treatment in Patients with Moderate to Severe Psoriasis
    Medical condition: Disease under investigation: Adult patients of both genders with moderate to severe chronic plaque psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other s...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-005718-20 Sponsor Protocol Number: 111315 Start Date*: 2015-04-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase 2, open, randomized, controlled, multi-center study to evaluate the safety and immunogenicity of 7 infant immunization schedules of the RTS,S/AS01E candidate vaccine against P. falciparum.
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001868-30 Sponsor Protocol Number: LP0160-1396 Start Date*: 2020-08-04
    Sponsor Name:LEO Pharma A/S
    Full Title: A phase 3, randomised, double-blind, multi-centre trial to evaluate the efficacy, safety, and tolerability of brodalumab treatment compared to placebo (blinded) and ustekinumab (open-label) in adol...
    Medical condition: Moderate-to-severe plaque psoriasis in adolescents from 12 to 17 years of age
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) NL (Completed) BE (Completed) IT (Prematurely Ended) HU (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-000121-40 Sponsor Protocol Number: CNTO1275PSO3013 Start Date*: 2016-05-02
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pedia...
    Medical condition: Moderate to Severe Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004858 10071117 Plaque psoriasis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) DE (Completed) PL (Completed) FR (Completed) NL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023901-36 Sponsor Protocol Number: UHK-GMD-LOA-04 Start Date*: 2011-04-12
    Sponsor Name:Faculty of Medicine, Otto-von-Guericke-University, Magdeburg
    Full Title: Psoriasis-topoproteome under ustekinumab treatment (PIROUETTE-Study) - as an interventional observation study (phase IV) within approved label and indication and with minimal invasive taking of ski...
    Medical condition: STELARA™ as IMP will be used in all relevant aspects (indication, contraindications, dosing) completely within the approved label, namely for the treatment of adult patients with moderate to severe...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-020002-15 Sponsor Protocol Number: A3921061 Start Date*: 2010-11-15
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS
    Medical condition: Moderate To Severe Chronic Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10040785 - Skin and subcutaneous tissue disorders 10037153 Psoriasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Completed) GB (Completed) NL (Completed) FI (Prematurely Ended) ES (Completed) DK (Prematurely Ended) SE (Prematurely Ended) BG (Prematurely Ended) SK (Prematurely Ended) HU (Prematurely Ended) AT (Completed) GR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000706-34 Sponsor Protocol Number: A3921237 Start Date*: 2014-10-06
    Sponsor Name:Pfizer Inc. 235 East 42nd Street, New York, NY 10017
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY TO ASSESS THE IMMUNE RESPONSE FOLLOWING ADMINISTRATION OF ZOSTER VACCINE TO SUBJECTS WITH RHEUMATOID ARTHRITIS RECEIVING TOFACITINIB (C...
    Medical condition: RHEUMATOID ARTHRITIS
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-003166-39 Sponsor Protocol Number: ChImDLP-2 Start Date*: 2022-08-08
    Sponsor Name:UAB Froceth
    Full Title: A study of the safety of chemoimmunotherapy with autologous Dendritic Cell Preparations in patients with stage III ovarian cancer
    Medical condition: Stage III of high malignancy Ovarian serous adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070907 Ovarian cancer stage III PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: LT (Prematurely Ended)
    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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