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Clinical trials for infanrix hexa and glaxosmithkline biologicals

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    The EU Clinical Trials Register currently displays   44346   clinical trials with a EudraCT protocol, of which   7374   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).

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    78 result(s) found for: infanrix hexa and glaxosmithkline biologicals. Displaying page 3 of 4.
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    EudraCT Number: 2006-003239-61 Sponsor Protocol Number: 107876 Start Date*: 2006-09-29
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologic...
    Medical condition: Two-dose immunisation at 3 and 4 months of age in healthy infants previously uninfected with HRV.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (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: 2014-001117-41 Sponsor Protocol Number: 201330 Start Date*: 2015-11-13
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of Infanrix hexa? administered as primary vaccination in healthy infants born to mothers given Boo...
    Medical condition: Healthy volunteers [Primary immunisation of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib)].
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10006025 Bordetella pertussis laryngotracheobronchitis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) Outside EU/EEA FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001511-12 Sponsor Protocol Number: 109861 Start Date*: 2015-06-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, single group, open study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in Taiwan when co-admini...
    Medical condition: Healthy volunteers (Three dose primary vaccination against Streptococcus pneumoniae, diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b diseases and a two dose primar...
    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: 2012-003026-25 Sponsor Protocol Number: RSRSG12-03 Start Date*: 2012-09-28
    Sponsor Name:Health Protection Agency
    Full Title: A phase IV study to evaluate the primary and booster immune responses of UK infants receiving a licensed 6-in-1 DTaP/IPV/Hib/HBV vaccine(Infanrix-Hexa™) with a 13-valent pneumococcal conjugate vacc...
    Medical condition: Not applicable
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-001449-93 Sponsor Protocol Number: 110031 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, observer-blind follow-up study with two groups to assess the reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine (GSK1024850...
    Medical condition: Healthy volunteers (Booster immunization of healthy children previously primed with three doses of pneumococcal conjugate vaccine or a two-dose catch-up immunization in unprimed children previously...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-007846-69 Sponsor Protocol Number: 112830 Start Date*: 2009-04-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Persistence of antibodies after full vaccination course with GSK Biologicals’ Menitorix or MenC conjugate vaccine, co-administered with DTPa or DTPa/Hib containing vaccine and pneumococcal conjugat...
    Medical condition: Healthy volunteers (prevention of invasive diseases caused by Haemophilus influenzae (type b) and Neisseria meningitidis serogroup C)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10027275 Meningococcal infection, unspecified LLT
    14.1 10042613 - Surgical and medical procedures 10069533 Haemophilus influenzae type b immunisation PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003451-38 Sponsor Protocol Number: OVG2018/05 Start Date*: 2019-02-21
    Sponsor Name:Clinical Trials and Research Governance (CTRG)
    Full Title: Immunogenicity and reactogenicity of concomitantly administered hexavalent and Group B meningococcal vaccines in infancy.
    Medical condition: Immunogenicity and reactogenicity of concomitantly administered hexavalent and group B meningococcal vaccines in infancy.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2011-002076-16 Sponsor Protocol Number: 109563 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Clinical Otitis Media and Pneumonia Study (COMPAS): a phase III , double-blind, randomized, controlled, multicentre study to demonstrate the efficacy of GlaxoSmithKline (GSK) Biologicals’ 10-valent...
    Medical condition: Three dose primary vaccination of healthy infants between 6-16 weeks of age at the time of the first vaccination, followed by a booster dose at 15-18 months.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    14.1 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021491-28 Sponsor Protocol Number: V419-008 Start Date*: 2012-01-26
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: A phase III randomized, double-blind, active-comparator controlled clinical trial to study the safety, tolerability, and immunogenicity of V419 in healthy infants when given at 2, 4, and 11 to 12 m...
    Medical condition: PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004848 10019743 Hepatitis B virus (HBV) LLT
    16.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    16.0 100000004865 10069593 Pertussis immunization LLT
    16.0 100000004865 10054181 Hepatitis B immunization LLT
    16.0 100000004865 10053386 Poliomyelitis vaccine LLT
    16.0 100000004865 10054180 Diphtheria immunization LLT
    16.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003523-30 Sponsor Protocol Number: 38RC17.191 Start Date*: 2017-12-18
    Sponsor Name:University Hospital Grenoble
    Full Title: Vaccination after hematopoietic stem cell transplantation : a randomized study estimating the interest of an additional injection for patients not reponding at M3.
    Medical condition: Our aim is to determine whether an additional dose of inactivated vaccine can increase the rate of responders among patients who have not responded adequately after 3 injections
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10067859 Allogenic stem cell transplantation LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000876-33 Sponsor Protocol Number: 114843 Start Date*: 2011-08-16
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, double-blind, multicentre study to evaluate the safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in heal...
    Medical condition: Healthy volunteers (toddlers): Booster immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10043376 Tetanus PT
    14.0 10021881 - Infections and infestations 10018952 Haemophilus influenzae infection LLT
    14.0 10021881 - Infections and infestations 10034738 Pertussis PT
    14.0 10021881 - Infections and infestations 10019731 Hepatitis B PT
    14.0 10021881 - Infections and infestations 10013023 Diphtheria PT
    14.0 10021881 - Infections and infestations 10036012 Poliomyelitis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) 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: 2009-016841-24 Sponsor Protocol Number: 113369 Start Date*: 2010-05-13
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: Estudio de fase IIIB, abierto, multinacional, aleatorizado y controlado para demostrar la no inferioridad de la respuesta inmunitaria a la vacuna antimeningocócica (serogrupos A, C, W-135 e Y) conj...
    Medical condition: Inmunización activa de lactantes frente a los serogrupos A, C, W-135 e Y de Neisseria meningitidis durante el primer año de vida, seguida de una dosis de recuerdo administrada a los 12 meses de edad.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10062371 Active immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000162-38 Sponsor Protocol Number: 113151 Start Date*: 2015-05-13
    Sponsor Name: GlaxoSmithKline Biologicals
    Full Title: A phase III open-label study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine when co-administered with GSK Biologicals’ Infanr...
    Medical condition: Healthy volunteers (for three-dose primary vaccination against Streptococcus pneumoniae in healthy infants between 6 to 12 weeks of age at the time of the first vaccination)
    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: 2012-002428-34 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: 2006-000518-19 Sponsor Protocol Number: 106672;106673;106675;106679;-80 Start Date*: 2006-04-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase III, open, multicentre study to assess the long-term persistence of a booster dose of GSK Biologicals? Hib-MenC conjugate vaccine compared to a booster dose of Infanrix? hexa (combined diph...
    Medical condition: The prevention of invasive diseases caused by Haemophilus influenzae type b and Neisseria meningitidis serogroup C.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    14.1 10021881 - Infections and infestations 10027274 Meningococcal infection PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-001986-34 Sponsor Protocol Number: T151/2019 Start Date*: 2019-11-19
    Sponsor Name:Turku University Hospital
    Full Title: Exploring the impact of pertussis immunization during pregnancy on the differences in immune response of infants after primary immunization with an acellular pertussis containing vaccine: an open l...
    Medical condition: Pertussis Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10034738 Pertussis PT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-003762-33 Sponsor Protocol Number: 106481 Start Date*: 2006-12-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, double blind, randomised, placebo–controlled, multi–country, multicentre study to assess the safety, reactogenicity and immunogenicity of two doses of GlaxoSmithKline (GSK) Biological...
    Medical condition: Primary immunisation of pre–term infants against human rotavirus gastroenteritis (GE)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-000943-26 Sponsor Protocol Number: 115375 Start Date*: 2011-05-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, open-label, study to assess the antibody persistence in healthy 5-year-old children, previously vaccinated at 3, 5 and 11months of age with GSK Biologicals’ DTPa-HBV-IPV/Hib or DTPa-IPV...
    Medical condition: Healthy volunteers (Immunogenicity of the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in terms of persistence of antibodies to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Hib vacc...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10043376 Tetanus PT
    13.1 10021881 - Infections and infestations 10018952 Haemophilus influenzae infection LLT
    13.1 10021881 - Infections and infestations 10034738 Pertussis PT
    13.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    13.1 10021881 - Infections and infestations 10013023 Diphtheria PT
    13.1 10021881 - Infections and infestations 10036012 Poliomyelitis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) NO (Completed)
    Trial results: View results
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