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Clinical trials for Hib vaccine

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
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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).

    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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    206 result(s) found for: Hib vaccine. Displaying page 1 of 11.
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    EudraCT Number: 2004-001249-14 Sponsor Protocol Number: 102547 Start Date*: 2004-10-18
    Sponsor Name:GlaxoSmithKline
    Full Title: A Phase III open, multicentre, booster vaccination study to assess the immunogenicity, safety and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type ...
    Medical condition: Booster vaccination against Haemophilus influenzae type b and meningococcal serogroup C diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-001530-25 Sponsor Protocol Number: 208109/232 Start Date*: 2015-06-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIb, open, randomized, controlled, multicenter study of the immunogenicity and safety of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine (Havrix) [720 El.U/ 0.5 mL dose] admin...
    Medical condition: Active immunization against hepatitis A, , diphtheria, tetanus, pertussis and Haemophilus influenza type B infections of healthy children 15 months of age at the time of the first study vaccination.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-005343-16 Sponsor Protocol Number: 111344 Start Date*: 2008-02-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged ...
    Medical condition: Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2007-000596-42 Sponsor Protocol Number: 109621 Start Date*: 2007-10-30
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III open study to assess the safety, reactogenicity and immunogenicity following booster administration of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine, co-ad...
    Medical condition: Booster vaccination against Streptococcus pneumoniae of healthy preterm born children between 16-18 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate ...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-003769-33 Sponsor Protocol Number: 103974, 104056 Start Date*: 2005-01-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III open (partially double-blind), controlled, multicenter, multicountry primary & booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C response of ...
    Medical condition: Three-dose primary vaccination course with a haemophilus influenzae type B and meningococcal serogroup C conjugate vaccine of infants starting between 6 to 12 weeks of age with one month interval b...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-000554-46 Sponsor Protocol Number: 106786 Start Date*: 2006-08-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine containing diphth...
    Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2012-004137-16 Sponsor Protocol Number: 114260 Start Date*: 2015-05-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, open-label, multicentre study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ combined DTPa-IPV/Hib vaccine administered as a three-...
    Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001513-27 Sponsor Protocol Number: 112065 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus in...
    Medical condition: Healthy volunteers (Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001507-31 Sponsor Protocol Number: 111535 Start Date*: 2015-06-09
    Sponsor Name:GlaxoSmithKline Biologicals - GSK China Vaccines
    Full Title: A phase IIIb, open-label, multicentre study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ combined diphtheria-tetanus-acellular pertussis (DTPa)- Haemophilus influen...
    Medical condition: Healthy volunteers (Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2012-003324-20 Sponsor Protocol Number: 114386 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open-label study to assess the immune persistence in healthy Chinese toddlers primed in infancy with three doses of GSK Biologicals’ DTPa-IPV/Hib vaccine, and to assess the safety and immunogeni...
    Medical condition: Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002439-26 Sponsor Protocol Number: 217744/100 Start Date*: 2015-02-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, multicentre, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3 and 4 months of age and ...
    Medical condition: Primary immunization of healthy infants against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002427-15 Sponsor Protocol Number: 105910 Start Date*: 2015-06-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, partially double-blind clinical trial to evaluate the immu-nogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (new formulation) as co...
    Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis diseases and, if applicable, 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: 2013-003428-34 Sponsor Protocol Number: 103506 Start Date*: 2015-05-04
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, non-randomised, open-label, multicentre study with two parallel groups to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine ad...
    Medical condition: Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-001628-38 Sponsor Protocol Number: 107046 Start Date*: 2006-07-26
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIa single-blind, controlled multicentre study to assess the safety, reactogenicity and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine or Prevenar when given as...
    Medical condition: Booster vaccination against Streptococcus pneumoniae in children 12 to 18 months old.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001508-37 Sponsor Protocol Number: 113681 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine, when administered as primary vaccination integrated int...
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria, immunization against hepatitis B)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002428-34 Sponsor Protocol Number: 110478 Start Date*: 2015-04-30
    Sponsor Name:GlaxoSmithKline Biolgicals
    Full Title: A phase IV, partially double-blind, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (new formulation) as co...
    Medical condition: Booster immunisation of healthy children against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-000558-30 Sponsor Protocol Number: 107005 Start Date*: 2006-06-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb randomised, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when co-admini...
    Medical condition: Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenza...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-005421-59 Sponsor Protocol Number: 106388-106390 Start Date*: 2006-03-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, randomized, controlled, multicentre, primary & booster study to demonstrate the non-inferiority of the MenC & Hib immune responses of GSK Biologicals’ Hib-MenC vaccine co-adminis...
    Medical condition: Two-dose primary immunization course in healthy infants in the first year of life with a booster dose at 11 months of age against Haemophilus influenzae type b and meningococcal serogroup C diseases.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006365-91 Sponsor Protocol Number: 111761 Start Date*: 2009-03-04
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open-label, randomised, multicentre study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine, when given in healthy infants at 3,...
    Medical condition: Primary and booster immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b and serogroup C menin...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed)
    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
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