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Clinical trials for 2011-002076-16

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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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: 2011-002076-16. Displaying page 1 of 1.
    EudraCT Number: 2011-002076-16 Sponsor Protocol Number: 109563 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Clinical Otitis Media and Pneumonia Study (COMPAS): a phase III , double-blind, randomized, controlled, multicentre study to demonstrate the efficacy of GlaxoSmithKline (GSK) Biologicals’ 10-valent...
    Medical condition: Three dose primary vaccination of healthy infants between 6-16 weeks of age at the time of the first vaccination, followed by a booster dose at 15-18 months.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    14.1 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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