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Clinical trials for Acute otitis media

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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    60 result(s) found for: Acute otitis media. Displaying page 3 of 3.
    « Previous 1  2  3 
    EudraCT Number: 2008-005149-48 Sponsor Protocol Number: 111442 Start Date*: 2009-02-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III/IV, cluster-randomized, controlled study to evaluate the effectiveness of GlaxoSmithKline Biologicals’ 10-valent pneumococcal and non-typeable Haemophilus influenzae protein D conjugate...
    Medical condition: Active immunization of children from the age of 6 weeks up to 18 months of age at the time of first vaccination, against Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F an...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    14.0 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2019-001186-33 Sponsor Protocol Number: AIV_FLU_2019_01_VIGIRA_JDD Start Date*: 2019-09-27
    Sponsor Name:FISABIO
    Full Title: Clinical trial, phase IV, randomized, double-blind, controlled, in children aged 12 to 35 months, of the vaccine against seasonal influenza to estimate efficacy against influenza and other respirat...
    Medical condition: Flu and acute respiratory infections
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001760-31 Sponsor Protocol Number: J0022XST302 Start Date*: 2013-07-04
    Sponsor Name:PIERRE FABRE MEDICAMENT
    Full Title: Clinical efficacy and safety of J022X ST in the prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) in children with a high risk of recurrence
    Medical condition: Recurrent Upper-Respiratory Tract Infections (RURTI)
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10046306 Upper respiratory tract infection PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) LT (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-003164-13 Sponsor Protocol Number: T17-081 Start Date*: 2018-05-17
    Sponsor Name:Haga Teaching Hospital (Juliana Children's Hospital)
    Full Title: Antibiotic prophylaxis for children with recurrent respiratory infections: towards evidence-based guidelines
    Medical condition: Recurrent respiratory tract infections in children
    Disease: Version SOC Term Classification Code Term Level
    25.1 100000004862 10038133 Recurrent respiratory tract infections LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003642-93 Sponsor Protocol Number: 53718678RSV2002 Start Date*: 2018-12-05
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses o...
    Medical condition: Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10066740 Acute respiratory tract infection LLT
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) ES (Prematurely Ended) HU (Completed) SE (Completed) FR (Completed) DE (Prematurely Ended) PL (Completed) BG (Completed) Outside EU/EEA IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000425-40 Sponsor Protocol Number: GV29893 Start Date*: 2016-08-03
    Sponsor Name:Genentech Inc.
    Full Title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF MHAA4549A, A MONOCLONAL ANTIBODY, ADMINISTERED AS MONOTHERAPY FOR THE TREATMENT OF ACUTE UNCOMPLICATED SEASONAL INFLUENZA A INFECTION...
    Medical condition: acute uncomplicated seasonal influenza
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10022002 Influenza A virus infection LLT
    19.0 100000004862 10022001 Influenza (epidemic) LLT
    19.0 100000004862 10016790 Flu LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-001018-13 Sponsor Protocol Number: BCX1812-305 Start Date*: 2021-03-31
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute U...
    Medical condition: acute uncomplicated influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-004734-37 Sponsor Protocol Number: NORM-01 Start Date*: 2021-12-14
    Sponsor Name:Octapharma Pharmazeutika Prod.Ges.m.b.H
    Full Title: Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with p...
    Medical condition: Primary Immunodeficiency Diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001862-56 Sponsor Protocol Number: 64041575RSV2004 Start Date*: 2018-01-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (...
    Medical condition: Respiratory syncytial virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) FI (Prematurely Ended) SK (Prematurely Ended) ES (Prematurely Ended) IE (Prematurely Ended) PT (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000758-41 Sponsor Protocol Number: 115345 Start Date*: 2011-09-26
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, observer-blind, randomized, multi-country, non-influenza vaccine comparator-controlled study to demonstrate the efficacy of GlaxoSmithKline Biologicals’ quadrivalent seasonal influenza...
    Medical condition: Healthy volunteers (Immunization against influenza A and/or B in children aged 6 months to 35 months).
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) BE (Completed) GB (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-003648-12 Sponsor Protocol Number: B1851009(6096A1-3010) Start Date*: 2012-02-20
    Sponsor Name:Wyeth Pharmaceuticals Inc. (a Pfizer company)
    Full Title: A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity, and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children
    Medical condition: prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-003708-77 Sponsor Protocol Number: 6096A1-3006_B1851007 Start Date*: 2012-03-07
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Impact of a 13-Valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization With Vaccine Serotypes of Streptococc...
    Medical condition: Prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001514-97 Sponsor Protocol Number: 114541 Start Date*: 2015-05-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 3, observer blind, randomized, non-influenza vaccine comparator-controlled, multi-country and multi-centre study of the efficacy of GSK Biologicals’ quadrivalent, inactivated, split virion,...
    Medical condition: Healthy volunteers (Immunization against influenza in male and female subjects 3 to 8 years of age inclusive)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001696-22 Sponsor Protocol Number: 64041575MPN2001 Start Date*: 2018-06-28
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine ...
    Medical condition: Human metapneumovirus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10066226 Metapneumovirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Temporarily Halted) PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-017498-39 Sponsor Protocol Number: OVG2009/4 Start Date*: 2010-03-18
    Sponsor Name:University of Oxford
    Full Title: A follow-on, multi-centre, open-label, clinical, phase 3 trial to investigate the persistence of serotype-specific antibodies at 40 months of age in children who have received either the 7-valent o...
    Medical condition: Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10042193 Streptococcus pneumoniae acute exacerbation of chronic bronchitis LLT
    12.1 10042194 Streptococcus pneumoniae meningitis LLT
    12.1 10042195 Streptococcus pneumoniae pneumonia LLT
    12.1 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    12.1 10042197 Streptococcus pneumoniae septicaemia LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-003290-15 Sponsor Protocol Number: GTI1503 Start Date*: 2016-05-12
    Sponsor Name:Grifols Therapeutics Inc.
    Full Title: A Multi-Centre, Open-Label, Single Arm Trial to Evaluate Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency
    Medical condition: Primary Immunodeficiency (PI) diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    20.0 10021428 - Immune system disorders 10045792 Unspecified disorder of immune mechanism LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) ES (Completed) DE (Completed) PL (Completed) HU (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-005588-24 Sponsor Protocol Number: AM-101-CL-12-03 Start Date*: 2014-05-27
    Sponsor Name:Auris Medical Inc.
    Full Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 (AMPACT1) – an open-label extension to the TACTT2 study
    Medical condition: Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-001527-39 Sponsor Protocol Number: AM-101-CL-12-04 Start Date*: 2013-11-21
    Sponsor Name:Auris Medical AG
    Full Title: AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 2 (AMPACT2) – an open-label extension to the TACTT3 study
    Medical condition: Treatment of peripheral tinnitus following traumatic cochlear injury or otitis media
    Disease: Version SOC Term Classification Code Term Level
    19.0 10013993 - Ear and labyrinth disorders 10043882 Tinnitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed) DE (Completed) AT (Completed) GB (Completed) PL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-004721-24 Sponsor Protocol Number: QHD00014 Start Date*: 2020-09-07
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Efficacy, Immunogenicity, and Safety of High-Dose Quadrivalent Influenza Vaccine Compared with Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months through 35 Months of Age
    Medical condition: Prevention of influenza infection in children 6 months through 35 months of age
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-003710-16 Sponsor Protocol Number: 112640 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, open, controlled study in healthy Japanese children to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate...
    Medical condition: Healthy volunteers (for active immunization against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 2 years of age)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    18.0 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    18.0 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    18.0 100000004862 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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