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Clinical trials for hepatitis B 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
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    • 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   44336   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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    276 result(s) found for: hepatitis B vaccine. Displaying page 1 of 14.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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: 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: 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: 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: 2013-002589-38 Sponsor Protocol Number: HBV-2013 Start Date*: 2013-07-11
    Sponsor Name:Universität Innsbruck, Institut für Biomedizinische Alternsforschung
    Full Title: Primary and booster vaccination in old age: Hepatitis A and Hepatitis B
    Medical condition: This study will analyze cellular and humoral immune reponses after primary or booster vaccination against HAV and HBV. Healthy adults will be vaccinated with a combination vaccine, which is license...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10054181 Hepatitis B immunization LLT
    16.1 100000004865 10063436 Hepatitis A immunization LLT
    16.1 100000004865 10068384 Hepatitis immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    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: 2005-005939-10 Sponsor Protocol Number: V232-055 Start Date*: 2006-05-15
    Sponsor Name:Merck & Co. Inc.
    Full Title: A study in healthy, young adults and healthy infants of the safety, tolerability, and immunogenicity of an investigational manufacturing process for the recombinant hepatitis B vaccine
    Medical condition: Hepatitis B ICD10 classification code : Hepatitis Viral- Type B (ICD10- B16) MedDRA classification code : Infections and Infestations – Viral Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    7.1 10019731 LLT
    Population Age: Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-022538-10 Sponsor Protocol Number: 112688 Start Date*: 2011-04-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (Engerix-B™ Kinder) vaccine challenge in children...
    Medical condition: Antibody persistence and hepatitis B vaccine challenge in children aged 7–8 years, previously primed and boosted with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) as part of...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019731 Hepatitis B LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 2008-004785-98 Sponsor Protocol Number: OVG2008/5 Start Date*: 2008-12-22
    Sponsor Name:University of Oxford
    Full Title: An observational study of children immunised in infancy against hepatitis B virus, evaluating the persistence of immunity and the immune response to a scheduled booster dose of hepatitis B vaccine
    Medical condition: The intended application of Engerix B is active immunisation against Hepatitis B virus infection caused by all known subtypes in non immune subjects.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052552 Hepatitis B virus LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000261-38 Sponsor Protocol Number: 108988 Start Date*: 2008-01-21
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, open, multicentric study to evaluate the immune response to a hepatitis B challenge dose in healthy subjects, 72 to 78 months after they received a primary vaccination course of GSK Bio...
    Medical condition: Hepatitis B vaccine challenge dose given to subjects, 17 to 21 years of age, to evaluate immune memory to Hepatitis B antigen, approximately 6 years after priming with Hepatitis B vaccine.
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022372-31 Sponsor Protocol Number: DV2-HBV-19 Start Date*: 2011-11-10
    Sponsor Name:Dynavax Technologies Corporation
    Full Title: An Observational Study Evaluating the Long-Term Safety and Immunogenicity of HEPLISAV™ Compared with Engerix-B® in Adults With Chronic Kidney Disease Who Have Previously Received a Hepatitis B Vacc...
    Medical condition: Prevention of Hepatitis B virus (HBV) infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004865 10054181 Hepatitis B immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016721-33 Sponsor Protocol Number: rHB01C Start Date*: 2010-09-09
    Sponsor Name:Sanofi Pasteur MSD S.N.C
    Full Title: A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥ 50 years old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
    Medical condition: Healthy subjects, active immunisation against Hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    12.1 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: 2017-002574-39 Sponsor Protocol Number: 207811 Start Date*: 2018-11-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Ancillary study evaluating ChAd155-hIi-HBV shedding in a subset of chronic hepatitis B patients enrolled in the first-time-in-human, Phase I/II, randomised, multi-centric, single-blind study TH HBV...
    Medical condition: Chronic hepatitis B
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004099-31 Sponsor Protocol Number: 116811 Start Date*: 2016-07-26
    Sponsor Name:Glaxosmithkline Biologicals
    Full Title: Long-term persistence of immunity to hepatitis B in adults vaccinated 20 to 30 years ago with Engerix™-B.
    Medical condition: Healthy volunteers (immunisation against infection caused by all known subtypes of hepatitis B virus).
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10019731 Hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001508-37 Sponsor Protocol Number: 113681 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine, when administered as primary vaccination integrated int...
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria, immunization against hepatitis B)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-000557-21 Sponsor Protocol Number: HEPBARE-2015-01 Start Date*: 2015-06-12
    Sponsor Name:Vall de Hebron Hospital
    Full Title: Immunogenicity and efficacy of the vaccine against Hepatitis B virus in immunosuppressed patients antiHBc positive with low titers of anti-HBs. Assessment of clinical usefulness in preventing react...
    Medical condition: Patients under immunosuppressant therapy with past hepatitis B infection (HBsAg -/antiHBc +) but low antiHBs titers.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10058827 Hepatitis B reactivation LLT
    18.0 10022891 - Investigations 10050542 Hepatitis B surface antigen negative PT
    18.0 10022891 - Investigations 10052328 Hepatitis B core antigen positive PT
    18.0 100000004865 10068384 Hepatitis immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002720-91 Sponsor Protocol Number: HBnr02 Start Date*: 2017-09-21
    Sponsor Name:CyTuVax BV
    Full Title: Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders.
    Medical condition: In a minority of the population (5-10%) standard vaccines against Hepatitis-B do not induce protective immunity, even after prolonged and repeated vaccination courses. Non- responsiveness to hepati...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000126-26 Sponsor Protocol Number: V419-013 Start Date*: 2020-07-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-...
    Medical condition: Long-term protection against HBV infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2022-002194-28 Sponsor Protocol Number: NL81713.078.22 Start Date*: 2023-03-20
    Sponsor Name:Erasmus MC
    Full Title: Phase I/II study to determine the safety, immunogenicity and efficacy of Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination (HEB-PEP-Study)
    Medical condition: HBeAg negative chronic HBV
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008910 Chronic hepatitis B PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    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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