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Clinical trials for 2011-002035-26

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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    The EU Clinical Trials Register currently displays   44334   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).

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    1 result(s) found for: 2011-002035-26. Displaying page 1 of 1.
    EudraCT Number: 2011-002035-26 Sponsor Protocol Number: 115411 Start Date*: 2011-10-21
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIb observer-blind, randomized, multicentre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine and Merck's Quadrivalent ...
    Medical condition: Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcino...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10033723 Papilloma viral infection NOS LLT
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008229 Cervical cancer LLT
    14.0 10038604 - Reproductive system and breast disorders 10056576 Cervical intraepithelial neoplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: FR (Completed) SE (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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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