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Clinical trials for 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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
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    81 result(s) found for: Otitis media. Displaying page 4 of 5.
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    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: 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: 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: 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: 2019-002939-28 Sponsor Protocol Number: OVX836-002 Start Date*: 2019-11-07
    Sponsor Name:OSIVAX
    Full Title: A phase 2a, single center, randomized, observer blind, controlled study to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine at two dose levels (90 µg and 180 μg), ...
    Medical condition: Healthy Volunteers (influenza Vaccine) Influenza infection is a major cause of respiratory disease that affects all age groups, leading to significant morbidity and mortality. Complications of infl...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    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: 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: 2016-002688-32 Sponsor Protocol Number: 1602T0832 Start Date*: 2017-11-07
    Sponsor Name:Shionogi Ltd.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared with Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients with Influenza at High Risk of Infl...
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10022005 Influenza viral infections HLT
    20.1 100000004862 10022002 Influenza A virus infection LLT
    20.1 100000004862 10022003 Influenza B virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LV (Completed) HU (Completed) GB (Completed) PL (Completed) BG (Completed) ES (Completed) BE (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2010-018564-17 Sponsor Protocol Number: FAV00A-IIA Start Date*: 2010-12-30
    Sponsor Name:Farmak International Holding GmbH
    Full Title: A Phase II, multicenter, multinational, randomized, double-blinded, placebo-controlled dose-finding study to evaluate the efficacy and safety of carbabenzpyride in the treatment of uncomplicated in...
    Medical condition: (Uncomplicated) Influenza A
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10022002 Influenza A virus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001855-15 Sponsor Protocol Number: QBGJ398-203 Start Date*: 2022-02-02
    Sponsor Name:QED Therapeutics, Inc.
    Full Title: Phase 2, Open-Label, Long-Term, Extension (OLE) Study of Infigratinib, an FGFR 1-3-Selective Tyrosine Kinase Inhibitor, in Children with Achondroplasia: PROPEL OLE
    Medical condition: Achondroplasia in Children
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10000452 Achondroplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 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: 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: 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: 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: 2006-002468-24 Sponsor Protocol Number: NV20234 Start Date*: 2008-02-13
    Sponsor Name:F.Hoffmann-La Roche Ltd.
    Full Title: A double-blind, randomized, stratified, multi-center trial evaluating conventional and high dose oseltamivir in the treatment of immunocompromised patients with influenza
    Medical condition: To investigate the optimal therapy for influenza in immunocompromised transplant recipients.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10022000 Influenza LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) FR (Completed) BE (Completed) HU (Completed) LT (Completed) CZ (Completed) EE (Completed) IT (Completed) GR (Prematurely Ended) BG (Completed) LV (Completed) DE (Completed)
    Trial results: View results
    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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