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Clinical trials for Dengue fever

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 ).  
     
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    19 result(s) found for: Dengue fever. Displaying page 1 of 1.
    EudraCT Number: 2023-000134-15 Sponsor Protocol Number: DEN-302 Start Date*: 2023-09-22
    Sponsor Name:Takeda
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to He...
    Medical condition: Dengue
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10012310 Dengue fever PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2022-003868-25 Sponsor Protocol Number: DEN-03-IB Start Date*: 2024-04-22
    Sponsor Name:Instituto Butantan
    Full Title: Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Dengue 1,2,3,4 (Attenuated) Vaccine produced by Instituto Butantan
    Medical condition: Dengue
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10012309 Dengue LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-003979-34 Sponsor Protocol Number: DEN-301 Start Date*: 2018-12-13
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy C...
    Medical condition: The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-003455-33 Sponsor Protocol Number: INV-DEN-203 Start Date*: 2022-12-21
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Age Descending and Expansion Phase 2 Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteer...
    Medical condition: Dengue Fever
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2024-000341-27 Sponsor Protocol Number: DEN-324 Start Date*: 2024-12-13
    Sponsor Name:Takeda
    Full Title: A Randomized, Double-Blind, Placebo-Controlled (Participants aged 18 to 60 years) and Open-Label (Participants aged 4 to 17 years), Phase 2/3 Trial to Evaluate the Immunogenicity and Safety of 2 do...
    Medical condition: Dengue fever
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10012312 Dengue fever virus infection LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2022-003339-24 Sponsor Protocol Number: DEN-308 Start Date*: 2022-12-21
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Phase 3, Open-Label, Randomized Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and an Intramuscu...
    Medical condition: Dengue fever
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-003456-13 Sponsor Protocol Number: DEN-313 Start Date*: 2022-12-21
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: An Open Label, Phase 2 Study to Investigate Cell-mediated Immunity and Safety of a Tetravalent Dengue Vaccine Candidate (TDV) Administered Subcutaneously in Healthy Children Aged 4 to 16 Years
    Medical condition: Dengue fever
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001071-23 Sponsor Protocol Number: DEN-314 Start Date*: 2018-03-26
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular H...
    Medical condition: Healthy Volunteers "Vaccination against Dengue Fever and co-administration with Hepatitis A vaccine"
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004501-30 Sponsor Protocol Number: V181-003 Start Date*: 2022-06-14
    Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [live, attenuated]) ...
    Medical condition: Prevention of dengue disease in toddlers, children, and adults in endemic areas, as well as travelers to endemic areas
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10012309 Dengue LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000994-22 Sponsor Protocol Number: CYD71 Start Date*: 2019-06-13
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Cervarix® in Healthy Female Subjects Aged 9 to 14 Years in Mexico
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever Human Papillomavirus Disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001714-26 Sponsor Protocol Number: CYD29 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly with Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000993-44 Sponsor Protocol Number: CYD63 Start Date*: 2019-06-13
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Given as a Booster Injection in Adolescents and Adults Who Previously Completed the 3-dose Schedule in a Study Conducted in Singapore
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003978-28 Sponsor Protocol Number: DEN-204 Start Date*: 2018-12-12
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Phase II, Double-Blind, Controlled Trial to Assess the Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Subjects Aged Between 2 a...
    Medical condition: Assessment of how different dosing schedules of the vaccine effect immunity to dengue fever in dengue endemic countries.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003136-23 Sponsor Protocol Number: CYD66 Start Date*: 2020-02-12
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001711-40 Sponsor Protocol Number: CYD24 Start Date*: 2014-05-26
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
    Medical condition: Prevention of symptomatic dengue disease
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000027-36 Sponsor Protocol Number: DEN-303 Start Date*: 2023-02-03
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and the Impact of a Booster Dose of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Are...
    Medical condition: Dengue fever
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-002854-25 Sponsor Protocol Number: CYD65 Start Date*: 2020-09-13
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of Tetravalent Dengue Vaccine Given in 1-, 2-, or 3-Dose Schedules (STAGE I) Followed by a Single Booster Injection of the Same Vaccine (STAGE II) 1 or 2 Years after the L...
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003135-36 Sponsor Protocol Number: CYD67 Start Date*: 2019-10-31
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Gardasil® in Healthy Subjects Aged 9 to 13 Years in Malaysia
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever Human Papillomavirus Disease
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-003980-77 Sponsor Protocol Number: DEN-315 Start Date*: 2018-12-13
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adoles...
    Medical condition: The purpose of this study is to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10012312 Dengue fever virus infection LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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