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Clinical trials for Hepatitis A

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   44381   clinical trials with a EudraCT protocol, of which   7393   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.
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    Query did not match any clinical trials.
    These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records.
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    Study title: Immunogenicity and safety of an inactivated Hepatitis A vaccine (80 AgU) after simultaneous administration with either Tetract-Hib+OPV or DtacP-IPC//Act-Hib vaccine in 16 to 19 month old toddlers (HAF29393) (1999)
    Active substance: Trivalent Oral Poliomyelitis Vaccine (Vero cells)
    Study summary document link (including results):
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    Document reference: 41299
    Study title: Clinical Safety Evaluation Study of sanofi pasteur’s AVAXIM 80U Pediatric Administered, at a First Step in 20 Healthy Adolescents, and at a Second Step in 20 Healthy Toddlers in China
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47490
    Study title: Comparative immunogenicity trial of Avaxim 80 vs Havrix 720 and Vaqta in 1-15 years old children
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47488
    Study title: Comparative study of two vaccination schedules of an inactivated Hepatitis A vaccine (80U) in Argentinean infants
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47486
    Study title: Immunogenicity and safety of an inactivated hepatitis A vaccine (80 AgU) after simultaneous administration with either TETRAct-HIB + OPV or DTacP-IPV//Act-HIB vaccine in 16 to 19 month-old toddlers
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 40918
    Study title: Immunogenicity and safety of AVAXIM-Pediatric and HAVRIX 720, in chilean subjects from 1 to 15 years of age
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47489
    Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - ASIA
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 40914
    Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - EUROPE
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 40913
    Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - SOUTH AMERICA Immunogenicity on a subgroup of Argentinean children
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47484
    Study title: Open study of immunogenicity and safety of the P.M. sv. hepatitis A vaccine (80 Antigen Units) in children - ISRAEL
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 40912
    Study title: Open study of safety and immunogenicity of the P.M. sv. hepatitis A vaccine (80 U) in Brasilian children
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47485
    Study title: Randomised open study of immunogenicity and safety of inactivated hepatitis a vaccine (80 U) in children: comparison of three vaccination shedules (0-6 months / 0-12 months / 0-18 months)
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 40917
    Study title: Safety and immunogenicity study of 3 consistency batches of inactivated hepatitis A vaccine (80 U) in children
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 40916
    Study title: Safety and immunogenicity study of a new paediatric inactivated Hepatitis A vaccine (80 U) in Taiwanese children
    Active substance: Hepatitis A Vaccine for Children (80 U/dose)
    Study summary document link (including results):
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    Document reference: 47487
    Study title:
    Active substance: Inactivated hepatitis A virus
    Study summary document link (including results):
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    Document reference: 41118
    Study title:
    Active substance: Inactivated hepatitis A virus
    Study summary document link (including results):
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    Document reference: 41120
    Study title:
    Active substance: Inactivated hepatitis A virus
    Study summary document link (including results):
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    Document reference: 47325
    Study title: A comparative study of the safety and immunogenicity of two dosing schedules of an inactivated Hepatitis A vaccine in healthy infants.
    Active substance: Inactivated hepatitis A virus
    Study summary document link (including results):
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    Document reference: 41121
    Study title: A comparative, double-blind, randomized study to compare the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine containing 360 EL.U injected according to a 0, 1 and 6 month schedule in healthy children.
    Active substance: Inactivated hepatitis A virus
    Study summary document link (including results):
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    Document reference: 47329
    Study title: A comparative, double-blind, randomized study to compare the immunogenicity and reactogenicity of SmithKline Beecham Biologicals' inactivated hepatitis A vaccine containing 360 EL.U injected according to a 0, 1 and 6 month schedule in healthy children.
    Active substance: Inactivated hepatitis A virus
    Study summary document link (including results):
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    Document reference: 47330
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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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