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Clinical trials for Twinrix

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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    16 result(s) found for: Twinrix. Displaying page 1 of 1.
    EudraCT Number: 2006-005999-41 Sponsor Protocol Number: 109063 Start Date*: 2007-01-23
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, open, controlled, multicenter primary vaccination study to demonstrate the non inferiority of the immunogenicity of GSK Biologicals’ meningococcal serogroup ACWY conjugate ...
    Medical condition: Primary immunization of healthy subjects aged 11 through 17 years against meningococcal serogroups A, C, W 135 and Y and/or hepatitis A and hepatitis B diseases
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2005-002171-33 Sponsor Protocol Number: HEPVACHIV Start Date*: 2005-09-14
    Sponsor Name:Aalborg Sygehus Syd
    Full Title: Hepatitis vaccination til patienter med HIV infektion. Betydning af adjuverende interleukin-2
    Medical condition: Patienter med Hiv infektion har øget risiko for hepatitis A og hepatitis B. Sundhedsmyndigheder anbefaler vaccination. Effekt er imidlertid mindre end for raske personer. Forsøget tester om adjuver...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-006083-11 Sponsor Protocol Number: 110699 to 110704 Start Date*: 2009-03-23
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open multicentre, multicountry study to evaluate long-term antibody persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vaccin...
    Medical condition: Adult subjects who received a primary vaccination course with Twinrix Adult following a two-dose schedule or Twinrix Junior following a three-dose schedule as adolescents (12-15 years) approximate...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-001517-27 Sponsor Protocol Number: 208127/084,100566/567/568/569/570 Start Date*: 2015-06-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open multicentre, multicountry study to evaluate long-term anti-body persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vacci...
    Medical condition: To protect healthy volunteers between the ages of 12 and 15 years against hepatitis A and hepatitis B viruses and to determine the optimal dose range and schedule of the combined hepatitis A / hepa...
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001515-12 Sponsor Protocol Number: 208127/120,/132,/133,/134,/137 Start Date*: 2015-06-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, randomized, multicentre, multicountry study to compare the reactogenicity and evaluate the safety and immunogenicity of GSK Bio’s combined hepatitis A / hepatitis B vaccine (at l...
    Medical condition: Vaccination of healthy children from 1 to 11 years old against Hepatitis
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005627-40 Sponsor Protocol Number: P12.130 Start Date*: 2012-09-19
    Sponsor Name:
    Full Title: Comparison of effectiveness of hepatitis B revaccination schemes in healthy non-responders
    Medical condition: previous non-response to hepatitis B vaccine (3 vaccinations, standard schedule)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-001516-35 Sponsor Protocol Number: 100561,100562,100563,100564,100565 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open study to evaluate the immunogenicity, safety, and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing...
    Medical condition: To protect healthy male and female children aged 1 to 11 years old included against hepatitis A and B.
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-014853-33 Sponsor Protocol Number: 112266 Start Date*: 2010-02-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open single centre study to evaluate the long-term antibody persistence and immune memory between 16 and 20 years after the primary study HAB-032 (208127/022) in which healthy adults were vaccin...
    Medical condition: Immunisation of healthy adults with Twinrix Adult
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-014275-53 Sponsor Protocol Number: 112267 Start Date*: 2009-10-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, single centre study to evaluate the long-term antibody persistence and immune memory between 16 and 20 years after the primary study HAB-028 (208127/021) in which healthy adults were vacc...
    Medical condition: Immunisation of healthy adults with Twinrix Adult
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004586-13 Sponsor Protocol Number: 117307 Start Date*: 2014-04-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Long-term hepatitis A and B antibody persistence in healthy adult subjects, primed 16 to 20 years earlier with GSK Biologicals’ combined hepatitis A and B vaccine, Twinrix® (SB208127) in study HAB-...
    Medical condition: Healthy volunteers (Vaccination against hepatitis A and hepatitis B in healthy adults)
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-000526-39 Sponsor Protocol Number: 111572 Start Date*: 2008-05-15
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, open, multicentre, multicountry study to evaluate the immune response to a challenge dose of GSK Biologicals’ Twinrix™ vaccine versus monovalent hepatitis A and B vaccines from differen...
    Medical condition: Healthy and non-healthy (including those taking medications) adults older than 41 years who participated in the primary vaccination study HAB-160 approximately 48 months ago.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004347-30 Sponsor Protocol Number: 110886 Start Date*: 2007-11-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biolog...
    Medical condition: For active immunization of females from the age of 10 years onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities includi...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: SE (Completed) HU (Completed) DK (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: 2011-001943-60 Sponsor Protocol Number: SJF0001 Start Date*: 2011-06-20
    Sponsor Name:Lars Jørgen Østergaard
    Full Title: Cellular immunity in adult Hepatitis B-vaccinated serologic non-responders
    Medical condition: Healthy individuals
    Disease: Version SOC Term Classification Code Term Level
    13.1 10022891 - Investigations 10060023 Interferon gamma level PT
    13.1 10042613 - Surgical and medical procedures 10054130 Hepatitis B immunisation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016773-15 Sponsor Protocol Number: HepVac Start Date*: 2010-01-13
    Sponsor Name:Matti Ristola
    Full Title: A Randomized, Controlled, Open-label Study of Comparing Immunogenicity of Sequential Hepatitis B and Hepatitis A Vaccination vs Vaccination with a Dual Hepatitis B and Hepatitis A Vaccine among HI...
    Medical condition: Immunisaatio A- ja B-hepatiittia vastaan HIV-infektoituneilla henkilöillä
    Disease: Version SOC Term Classification Code Term Level
    12.0 10021430 Immunisation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001333-17 Sponsor Protocol Number: V59_53 Start Date*: 2011-09-14
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vacci...
    Medical condition: To Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (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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