Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Hep G2

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   44343   clinical trials with a EudraCT protocol, of which   7372   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    6 result(s) found for: Hep G2. Displaying page 1 of 1.
    EudraCT Number: 2012-001055-39 Sponsor Protocol Number: A3L39 Start Date*: 2013-11-22
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Phase III, multi-center trial in 795 infants in the Czech Republic, Germany, and Spain. Subjects from the Czech Republic and Germany will be randomized in Groups 1 and 2 to receive in a blind-obser...
    Medical condition: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus in...
    Disease: Version SOC Term Classification Code Term Level
    17.0 10042613 - Surgical and medical procedures 10036897 Prophylactic vaccination LLT
    17.0 10042613 - Surgical and medical procedures 10043413 Therapeutic procedures and supportive care NEC HLGT
    17.0 10042613 - Surgical and medical procedures 10021430 Immunisation PT
    17.0 10042613 - Surgical and medical procedures 10021431 Immunisations HLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-005547-24 Sponsor Protocol Number: HXM01C Start Date*: 2013-03-07
    Sponsor Name:Sanofi Pasteur MSD
    Full Title: A phase III open-label randomised study to evaluate the immunogenicity and safety of the concomitant administration of a new Hexavalent DTaP-IPV-HepB-PRP-T combined vaccine (Hexavalent vaccine) giv...
    Medical condition: Healthy infants 46 to 74 days of age (both inclusive)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10054187 Polio immunization LLT
    17.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    17.0 100000004865 10069593 Pertussis immunization LLT
    17.0 100000004865 10054181 Hepatitis B immunization LLT
    17.0 100000004865 10054180 Diphtheria immunization LLT
    17.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-021490-37 Sponsor Protocol Number: V419-007 Start Date*: 2011-03-09
    Sponsor Name:Sanofi Pasteur MSD
    Full Title: A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months.
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054130 Hepatitis B immunisation PT
    14.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    14.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    14.1 10042613 - Surgical and medical procedures 10069543 Hemophilus influenzae type b immunization LLT
    14.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    14.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    14.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FI (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004108-39 Sponsor Protocol Number: V419-006 Start Date*: 2012-02-20
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: A Phase III Randomized, Partially Double-Blind, Active- Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy I...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054130 Hepatitis B immunisation PT
    14.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    14.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    14.1 10042613 - Surgical and medical procedures 10069543 Hemophilus influenzae type b immunization LLT
    14.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    14.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    14.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004095-10 Sponsor Protocol Number: V419-005 Start Date*: 2012-02-20
    Sponsor Name:Sanofi Pasteur Limited
    Full Title: A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Conco...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054130 Hepatitis B immunisation PT
    14.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    14.1 10042613 - Surgical and medical procedures 10053386 Poliomyelitis vaccine LLT
    14.1 10042613 - Surgical and medical procedures 10069543 Hemophilus influenzae type b immunization LLT
    14.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    14.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    14.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021491-28 Sponsor Protocol Number: V419-008 Start Date*: 2012-01-26
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: A phase III randomized, double-blind, active-comparator controlled clinical trial to study the safety, tolerability, and immunogenicity of V419 in healthy infants when given at 2, 4, and 11 to 12 m...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    16.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    16.0 100000004865 10069593 Pertussis immunization LLT
    16.0 100000004865 10054181 Hepatitis B immunization LLT
    16.0 100000004865 10053386 Poliomyelitis vaccine LLT
    16.0 100000004865 10054180 Diphtheria immunization LLT
    16.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Jun 14 05:54:16 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA