Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Whole-cell 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   44364   clinical trials with a EudraCT protocol, of which   7388   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    16 result(s) found for: Whole-cell vaccines. Displaying page 1 of 1.
    EudraCT Number: 2014-003474-16 Sponsor Protocol Number: Dukoral+Vivotif Start Date*: 2015-08-26
    Sponsor Name:Helsinki University Hospital
    Full Title: Immunity elicited by concomitant administration of oral typhoid fever (Vivotif®) and cholera (Dukoral®) vaccines
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000645-31 Sponsor Protocol Number: 113264 Start Date*: 2016-06-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, partially double-blind, randomised, controlled, single-centre study to assess the immunogenicity and reactogenicity of three different formulations of GSK Biologicals’ DTPw-HBV-IPV/Hib ...
    Medical condition: Booster immunisation against poliomyelitis disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001789-13 Sponsor Protocol Number: 2016/02 Start Date*: 2020-01-13
    Sponsor Name:Clinical Trials and Research Governance (CTRG), University of Oxford
    Full Title: A randomised, open label study, exploring the differences in immunogenicity and reactogenicity of infants after immunisation with either an acellular (aP) or whole cell pertussis (wP) vaccine
    Medical condition: This study is going to focus on the immunisations against pertussis disease in previous healthy children, but the disease itself is not going to be study.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10034738 Pertussis PT
    21.1 10021881 - Infections and infestations 10047976 Whooping cough due to bordetella pertussis (B. pertussis) LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-004380-44 Sponsor Protocol Number: 112899 Start Date*: 2015-05-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, open-label, randomised controlled study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine (M72/AS01E) when administered i...
    Medical condition: Healthy volunteers (evaluation of safety and reactogenicity of TB vaccine when administered in healthy infants)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003678-42 Sponsor Protocol Number: IIV-316 Start Date*: 2017-09-01
    Sponsor Name:RIVM [...]
    1. RIVM
    2. Clinical Trials and Research Governance
    3. Turun Yliopisto
    Full Title: Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background. An international study in Finland, the Netherlands...
    Medical condition: Pertussis infection
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) FI (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-005718-20 Sponsor Protocol Number: 111315 Start Date*: 2015-04-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase 2, open, randomized, controlled, multi-center study to evaluate the safety and immunogenicity of 7 infant immunization schedules of the RTS,S/AS01E candidate vaccine against P. falciparum.
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria)
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003136-23 Sponsor Protocol Number: CYD66 Start Date*: 2020-02-12
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially with Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines
    Medical condition: Dengue Fever Dengue Hemorrhagic Fever
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002145-11 Sponsor Protocol Number: B1971015(6108A1-2005) Start Date*: 2013-05-23
    Sponsor Name:Pfizer Inc
    Full Title: A Phase 2, Randomized, Active-controlled, observer-blindED Trial, to Assess the Safety, Tolerability, and Immunogenicity of MCV4, TDAP Vaccine and bivalent RLP2086 Vaccine When Administered Concomi...
    Medical condition: Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B (MnB) in adolescents and young adults, aged 10 through 25 years.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10004049 Bacterial meningitis LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001539-19 Sponsor Protocol Number: 104298 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine, when incorporated into an Expanded Program on ...
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-013411-36 Sponsor Protocol Number: VTdaP-01 Start Date*: 2009-12-08
    Sponsor Name:Statens Serum Institut
    Full Title: Immunogenicity and safety of a tetanus, diphtheria and mono component acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as a booster vaccination t...
    Medical condition: The intended use of the vaccine in this study is to increase the immunological protection against pertussis in adults who completed primary vaccination with diphtheria, tetanus and pertussis vaccin...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10034738 Pertussis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-000254-64 Sponsor Protocol Number: 114056 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell...
    Medical condition: Active immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    17.1 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: 2006-000557-21 Sponsor Protocol Number: 107007 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb randomized, double-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine compar...
    Medical condition: Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 12 weeks of age at the time of the first vaccination against Streptococcus pneumoniae)
    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
    EudraCT Number: 2012-002727-15 Sponsor Protocol Number: 114174 Start Date*: 2015-06-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, controlled, observer-blind study to evaluate the impact of two formulations of GlaxoSmithKline (GSK) Biologicals’ combined 10-valent pneumococcal polysaccharide and non-type...
    Medical condition: Healthy volunteers (for one-dose vaccination of healthy children between 2-4 years of age at the time of vaccination against Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. ...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    18.0 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    18.0 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    18.0 100000004862 10018954 Haemophilus influenzae secondary bacterial infection of acute bronchitis LLT
    18.0 100000004862 10042194 Streptococcus pneumoniae meningitis LLT
    18.0 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    18.0 100000004862 10018953 Haemophilus influenzae meningitis LLT
    18.0 100000004862 10018952 Haemophilus influenzae infection LLT
    18.0 100000004862 10058214 Septicaemia due to Haemophilus influenzae (H. influenzae) LLT
    18.0 100000004862 10035680 Pneumonia due to Haemophilus influenzae (H. influenzae) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-005716-26 Sponsor Protocol Number: 110021 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double blind (observer-blind), randomized, controlled multi-center study to evaluate, in infants and children, the efficacy of the RTS,S/AS01E candidate vaccine against malaria disease...
    Medical condition: Healthy volunteers (Primary and booster immunization against Plasmodium falciparum malaria)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004644-22 Sponsor Protocol Number: 111188 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, single-blind, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3...
    Medical condition: Healthy volunteers (Three dose primary vaccination of healthy infants between 6 to 10 weeks of age at the time of the first vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertus...
    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
    EudraCT Number: 2011-004650-25 Sponsor Protocol Number: 110521 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, open, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose pr...
    Medical condition: Healthy volunteers (Three dose primary vaccination of healthy infants against Streptococcus pneumonia, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and polio diseases)
    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
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Nov 16 16:44:49 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA