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Clinical trials for Ad26.COV2.S

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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    19 result(s) found for: Ad26.COV2.S. Displaying page 1 of 1.
    EudraCT Number: 2020-005801-14 Sponsor Protocol Number: VAC31518COV3003 Start Date*: 2021-02-15
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults
    Medical condition: Healthy Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-002584-63 Sponsor Protocol Number: VAC31518COV2001 Start Date*: 2020-09-02
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults ...
    Medical condition: Healthy Volunteers (Prevention of COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Restarted) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003643-29 Sponsor Protocol Number: VAC31518COV3009 Start Date*: 2020-11-10
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older E...
    Medical condition: Healthy Volunteers, with or without comorbidities (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) ES (Temporarily Halted) BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003953-43 Sponsor Protocol Number: VAC31518COV3005 Start Date*: 2021-11-29
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older
    Medical condition: Healthy Volunteers (Prevention of COVID-19 and influenza)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    21.1 100000004865 10059430 Influenza immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-005330-14 Sponsor Protocol Number: VAC31518COV2004 Start Date*: 2021-04-06
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants.
    Medical condition: Healthy Pregnant Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005720-11 Sponsor Protocol Number: VAC31518COV3006 Start Date*: 2021-04-22
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy ...
    Medical condition: Healthy Volunteers (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-001483-28 Sponsor Protocol Number: VAC31518COV1001 Start Date*: 2020-07-14
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Ye...
    Medical condition: Healthy volunteers (Prevention of COVID-19)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-005509-28 Sponsor Protocol Number: 901452-CT-21-001 Start Date*: 2022-02-10
    Sponsor Name:Akston Biosciences Corporation
    Full Title: Anti-COVID19 VaccinaTion AKS-452X BOOSTER Study (ACT-BOOSTER study)
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002327-38 Sponsor Protocol Number: NL77670.029.21 Start Date*: 2021-05-26
    Sponsor Name:Academic Medical Center
    Full Title: PREGCOVAC-19: the follow up of pregnant women who received COVID-19 vaccination in the Dutch national vaccination program
    Medical condition: Pregnant women aged ≥ 18 years who are scheduled for COVID-19 vaccination within the Dutch national vaccination program with any of the currently or future available vaccines that are used for preg...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    21.1 100000004868 10036586 Pregnant LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-003188-90 Sponsor Protocol Number: ENFORCE-PLUS Start Date*: 2021-07-01
    Sponsor Name:CHIP - Rigshospitalet - University of Copenhagen
    Full Title: A Phase IV Vaccine Study under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE PLUS)
    Medical condition: The primary objective of the study is to assess if the SARS-CoV-2 vaccine Johnson & Johnson/Janssen results in change in number and activation of platelets and anti-PF4 level. As well as to compare...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005752-38 Sponsor Protocol Number: CBAF312ADE03 Start Date*: 2021-03-18
    Sponsor Name:Novartis Pharma GmbH
    Full Title: An open-label multicenter study to assess response to SARS-CoV-2 modRNA vaccines in participants with secondary progressive multiple sclerosis treated with Mayzent (siponimod) (AMA-VACC)
    Medical condition: secondary progressive multiple sclerosis (SPMS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004719-10 Sponsor Protocol Number: AC-058B303 Start Date*: 2017-10-02
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis
    Medical condition: relapsing multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10063400 Secondary progressive multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) SE (Completed) PL (Completed) CZ (Completed) BG (Completed) LV (Completed) HU (Completed) LT (Completed) PT (Completed) HR (Completed) GB (GB - no longer in EU/EEA) FI (Completed) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2021-001459-15 Sponsor Protocol Number: HS-2021-02 Start Date*: 2021-04-26
    Sponsor Name:Medical University of Graz
    Full Title: Immune response to COVID-19 Vaccination in people with Diabetes Mellitus - COVAC-DM study
    Medical condition: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2020-006003-42 Sponsor Protocol Number: ENFORCE Start Date*: 2020-12-30
    Sponsor Name:CHIP - Rigshospitalet - University of Copenhagen
    Full Title: National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE)
    Medical condition: The aim is to study primarily effectiveness as well as safety of citizens being vaccinated with one of the SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme. Whereas ongoi...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-001512-28 Sponsor Protocol Number: COVIM Start Date*: 2021-05-11
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: Immunogenicity of COVID-19 vaccines in medical staff and special risk populations
    Medical condition: SARS-CoV-2 immunogenicity
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-004558-44 Sponsor Protocol Number: 2021-00604 Start Date*: 2021-10-10
    Sponsor Name:UMCG
    Full Title: Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients
    Medical condition: COVID-19 is associated with severely increased morbidity and mortality in kidney transplant patients. Available data show that the immune response after a standard regimen of two mRNA vaccinations ...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    23.1 100000004865 10084464 COVID-19 immunization LLT
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    23.1 10022891 - Investigations 10084508 COVID-19 antibody test LLT
    20.0 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    20.0 100000004865 10023438 Kidney transplant LLT
    23.0 100000004862 10084270 SARS-CoV-2 acute respiratory disease LLT
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    23.0 100000004865 10084462 SARS-CoV-2 vaccination LLT
    23.0 100000004865 10084463 SARS-CoV-2 immunisation LLT
    23.0 100000004865 10084466 SARS-CoV-2 immunization LLT
    23.1 10022891 - Investigations 10084501 SARS-CoV-2 antibody test PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-002927-39 Sponsor Protocol Number: BOOST_TX/RESCUE_TX Start Date*: 2021-06-13
    Sponsor Name:Medical University of Vienna
    Full Title: Preventive strategies against SARS-CoV-2 in kidney transplant recipients: Intervention A – vaccination: Single blinded randomized controlled trial on BNT162b2 or mRNA-1273 (mRNA) vs Ad26COVS1 or C...
    Medical condition: Intervention A - vaccination Patients following kidney transplant recipients who do not have an adequate immune response against SARS-CoV-2 following two doses of an mRNA vaccine Substudy A: kidne...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003370-41 Sponsor Protocol Number: VAT00002 Start Date*: 2021-08-23
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines with AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SA...
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-001520-18 Sponsor Protocol Number: NL76839.042.21 Start Date*: 2021-04-09
    Sponsor Name:RECOVAC consortium
    Full Title: Long term efficacy and safety of SARS-CoV-2 vaccination in Dutch patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation
    Medical condition: COVID-19 is associated with increased morbidity and mortality in kidney transplant recipients (KTR) and patients with chronic kidneydisease (CKD). Therefore, potential efficacious SARS-CoV-2 vaccin...
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    23.1 10042613 - Surgical and medical procedures 10084464 COVID-19 immunization LLT
    23.1 10042613 - Surgical and medical procedures 10084465 COVID-19 vaccination LLT
    23.1 100000004848 10084508 COVID-19 antibody test LLT
    23.0 100000004862 10084270 SARS-CoV-2 acute respiratory disease LLT
    23.0 100000004862 10084272 SARS-CoV-2 infection LLT
    23.0 10042613 - Surgical and medical procedures 10084462 SARS-CoV-2 vaccination LLT
    23.0 10042613 - Surgical and medical procedures 10084463 SARS-CoV-2 immunisation LLT
    20.0 10021428 - Immune system disorders 10023439 Kidney transplant rejection PT
    20.0 10042613 - Surgical and medical procedures 10023438 Kidney transplant LLT
    20.0 10042613 - Surgical and medical procedures 10061105 Dialysis PT
    20.0 10042613 - Surgical and medical procedures 10018875 Haemodialysis PT
    20.0 10042613 - Surgical and medical procedures 10034660 Peritoneal dialysis PT
    23.1 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    23.1 10038359 - Renal and urinary disorders 10076412 Chronic kidney disease stage 5 LLT
    23.1 10038359 - Renal and urinary disorders 10076411 Chronic kidney disease stage 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (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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