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Clinical trials for vaccines

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   43871   clinical trials with a EudraCT protocol, of which   7290   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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    901 result(s) found for: vaccines. Displaying page 1 of 46.
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    EudraCT Number: 2015-000133-70 Sponsor Protocol Number: V130_03 Start Date*: 2015-01-09
    Sponsor Name:Novartis Vaccines and Diagnostics, Inc
    Full Title: A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based...
    Medical condition: Prophylaxis of A Three Influenza Vaccines in Children Ages 4 Years Old to Less Than 18 Years Old
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-003339-22 Sponsor Protocol Number: V70P2E1 Start Date*: 2007-10-11
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase II, Observer-Blind, Parallel Groups, Single-Center, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of FLUAD or Vaxigrip Influenza Vaccines i...
    Medical condition: Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2007-002871-15 Sponsor Protocol Number: V58P13 Start Date*: 2007-09-14
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Assess Clinical Efficacy of a Cell-Derived Subunit Influenza Vaccine and an Egg-Derived Subunit Influenza Vaccine i...
    Medical condition: Influenza disease.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2009-012591-27 Sponsor Protocol Number: VAC037 Start Date*: 2009-11-16
    Sponsor Name:University of Oxford
    Full Title: A phase I/IIa study to assess the safety and immunogenicity of new malaria vaccine candidates AdCh63 MSP1 alone and with MVA MSP1
    Medical condition: Plasmodium Falciparum Malaria
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-004498-17 Sponsor Protocol Number: V71_18 Start Date*: 2014-11-13
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Trivalent Subunit Inactivated Influenza Vaccine (Agriflu™) in Healthy Child...
    Medical condition: Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004543-12 Sponsor Protocol Number: V70P6 Start Date*: 2014-11-04
    Sponsor Name:Novartis Vaccines and Diagnostics Srl.
    Full Title: A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Fluad® and Fluzone® Influenza Vaccines in Healthy Children Age...
    Medical condition: Influenza
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-000475-14 Sponsor Protocol Number: V59_38 Start Date*: 2011-10-25
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in He...
    Medical condition: Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10027202 Meningitis bacterial PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-001223-13 Sponsor Protocol Number: V58_31 Start Date*: 2014-12-03
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in Embryonated Ch...
    Medical condition: Prophylaxis: Influenza
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003210-27 Sponsor Protocol Number: 201663 Start Date*: 2017-07-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with t...
    Medical condition: PCV-free HRV vaccine is indicated to prevent gastroenteritis (GE) caused by rotavirus (RV)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-018603-29 Sponsor Protocol Number: V70_25S Start Date*: 2010-05-17
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2010-201...
    Medical condition: Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059430 LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005128-91 Sponsor Protocol Number: V71_21 Start Date*: 2014-11-26
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: Evaluating the safeness of Agrippal® S1 in preventing flu on Vietnamese volunteers.
    Medical condition: Prophylaxis for seasonal flu.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003167-30 Sponsor Protocol Number: 112679 Start Date*: 2015-04-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A randomised, open-label study to assess the immunogenicity and reactogenicity of GSK Biologicals’ IPV vaccine administered as a three-dose primary vaccination course at 2-3-4 months of age in heal...
    Medical condition: Primary immunisation of healthy infants in the first year of life against poliomyelitis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004497-24 Sponsor Protocol Number: 106227, 106228, 108736, 108738 Start Date*: 2006-10-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Observer-blinded, randomised, controlled, phase I/II study, to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis vaccines M72/AS01B and M72/AS02A wh...
    Medical condition: Vaccination against tuberculosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002083-13 Sponsor Protocol Number: HPVfollowup Start Date*: 2016-07-21
    Sponsor Name:Public Health England
    Full Title: An observational follow up study of a randomised parallel group phase IV study to evaluate the duration of the immune response to vaccine and non-vaccine HPV types in UK adolescent females who rece...
    Medical condition: No specific medical condition - immune reponses to HPV vaccination.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10042613 - Surgical and medical procedures 10071146 Human papilloma virus immunisation PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000085-38 Sponsor Protocol Number: V70_39S Start Date*: 2012-03-08
    Sponsor Name:NOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    Full Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2012-201...
    Medical condition: Clinical Trial on healthy volunteers (Active immunisation against influenza in the elderly (65 years of age and over), especially for those with an increased risk of associated complications (i.e. ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004416-66 Sponsor Protocol Number: VAC052 Start Date*: 2012-11-26
    Sponsor Name:University of Oxford
    Full Title: A Phase I/IIa Sporozoite Challenge Study to Assess the Efficacy of Candidate Combination Malaria Vaccine Approaches using the ChAd63 and MVA vectors encoding the antigens ME-TRAP, CS and AMA1.
    Medical condition: Plasmodium falciparum Infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-005871-14 Sponsor Protocol Number: V87P1 Start Date*: 2006-01-30
    Sponsor Name:CHIRON
    Full Title: A Phase II, Randomized, Controlled, Observer-blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two FLUAD-like Surface Antigen Adjuvan...
    Medical condition: Active influenza immunization pandemic strains
    Disease: Version SOC Term Classification Code Term Level
    6.1 10022000 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015997-36 Sponsor Protocol Number: 113809 Start Date*: 2009-10-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological non-inferiority of two manufacturing processes of the A/California/7/2009 (H1N1)v-lik...
    Medical condition: Immunization against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 to 60 years.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005159-24 Sponsor Protocol Number: M37P2 Start Date*: 2014-12-23
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase III, observer-blind, randomized, controlled, multi-center study to inventigate the immunogenicity and safety of the Vaxem Hib™ in 2-4 months old healthy infants in China, according to the r...
    Medical condition: Invasive Haemophilus influenzae type b disease
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005105-20 Sponsor Protocol Number: V48P4E3 Start Date*: 2014-11-28
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A phase IV, uncontrolled, open-label, multi-center study in children and adolescents: Evaluation of long-term immunogenicity in subjects boosted with a new pediatric TBE vaccine (free of protein-de...
    Medical condition: Prophylaxis: Tick-borne-encephalitis
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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