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Clinical trials for Haemophilus influenzae type b vaccine

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    The EU Clinical Trials Register currently displays   44349   clinical trials with a EudraCT protocol, of which   7376   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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    168 result(s) found for: Haemophilus influenzae type b vaccine. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2011-005032-26 Sponsor Protocol Number: 106445, Start Date*: 2015-06-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, randomized, controlled, multi-centre study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmith...
    Medical condition: Healthy volunteers (for primary immunization against meningococcal serogroup C and booster immunization against Haemophilus influenzae type b diseases of healthy children aged 12-18 months)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10028911 Neisseria meningitidis infection NOS LLT
    18.0 100000004848 10070120 Haemophilus influenzae test positive LLT
    18.0 100000004862 10018953 Haemophilus influenzae meningitis LLT
    18.0 10042613 - Surgical and medical procedures 10069533 Haemophilus influenzae type b immunisation PT
    18.0 100000004848 10070124 Neisseria meningitidis test positive LLT
    18.0 100000004862 10018952 Haemophilus influenzae infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-002898-47 Sponsor Protocol Number: 107737 Start Date*: 2007-01-16
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix h...
    Medical condition: Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2005-006066-34 Sponsor Protocol Number: 105987,105988 Start Date*: 2015-06-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, single-blind, randomized, controlled, multinational study for the evaluation of safety of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-t...
    Medical condition: Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10028911 Neisseria meningitidis infection NOS LLT
    18.0 100000004862 10018953 Haemophilus influenzae meningitis LLT
    18.0 100000004862 10018952 Haemophilus influenzae infection 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: 2014-005136-33 Sponsor Protocol Number: V37_07 Start Date*: 2014-11-28
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Vaxem Hib to HIBERIX® Using a Local Dosing Regimen in Infants
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-016579-31 Sponsor Protocol Number: OVG2008/6 Start Date*: 2010-01-14
    Sponsor Name:University of Oxford
    Full Title: An open label randomised controlled study to evaluate the induction of immune memory following infant vaccination with a glyco-conjugate Neisseria meningitidis serogroup C vaccine and to assess the...
    Medical condition: Active immunisation of children for the prevention of invasive diseases caused by Neisseria meningitidis serogroup C, Streptococcus pneumoniae, diphtheria, tetanus, pertussis, poliomyelitis and inv...
    Disease: Version SOC Term Classification Code Term Level
    12.0 10028911 Neisseria meningitidis infection NOS LLT
    12.1 10042194 Streptococcus pneumoniae meningitis LLT
    12.1 10042195 Streptococcus pneumoniae pneumonia LLT
    12.1 10035648 Pneumococcal pneumonia [Streptococcus pneumoniae pneumonia] LLT
    12.1 10042197 Streptococcus pneumoniae septicaemia LLT
    12.1 10018952 Haemophilus influenzae infection LLT
    12.1 10018953 Haemophilus influenzae meningitis LLT
    12.1 10035680 Pneumonia due to Haemophilus influenzae (H. influenzae) LLT
    12.1 10058214 Septicaemia due to haemophilus influenzae (H. influenzae) LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-005036-33 Sponsor Protocol Number: M37P1 Start Date*: 2014-11-18
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A phase I study to investigate safety and reactogenicity of Vaxem Hib in healthy children aged 16 – 20 months and infants aged 2 - 4 months.
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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
    EudraCT Number: 2015-001453-32 Sponsor Protocol Number: V37_07E2 Start Date*: 2015-04-29
    Sponsor Name:Novartis Vaccines and Diagnostics Srl
    Full Title: A Phase IIIb, Controlled, Open Label, Single-Center, Persistency, Extension study in Chinese children after a 2 + 1 dose series of either CRM197- conjugate Haemophilus influenzae type b vaccine or ...
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-000750-11 Sponsor Protocol Number: 200799 Start Date*: 2015-05-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Study to compare immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose presentation to the licensed Synflorix™ (10Pn-PD-DiT) vaccine when co-administered with DTPw-combination vaccine in healthy in...
    Medical condition: Infections, Pneumococcal
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside 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: 2014-005135-13 Sponsor Protocol Number: V37_07E1 Start Date*: 2014-11-28
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Phase III Observer blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2014-005203-24 Sponsor Protocol Number: V37_11 Start Date*: 2014-12-10
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Post Marketing Surveillance Study to monitor the reactogenicity and safety of Vaxem™Hib when administered according to the prescribing information in Korea
    Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2021-006686-37 Sponsor Protocol Number: SH600009 Start Date*: 2022-02-18
    Sponsor Name:Sanofi Pasteur
    Full Title: Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (SHAN6™) Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand
    Medical condition: Diphtheria, Tetanus, Pertussis, Hepatitis-B, invasive Haemophilus influenzae type b and Poliomyelitis diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054175 Polio immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054181 Hepatitis B immunization LLT
    21.1 10042613 - Surgical and medical procedures 10069533 Haemophilus influenzae type b immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054131 Tetanus immunisation PT
    21.1 10042613 - Surgical and medical procedures 10076886 Rotavirus immunisation PT
    21.1 10042613 - Surgical and medical procedures 10069578 Pneumococcal immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002077-35 Sponsor Protocol Number: 111634 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6,...
    Medical condition: 3- or 2-dose primary vaccination against Streptococcus pneumoniae together with a 3-dose primary vaccination against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b di...
    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: 2010-019730-27 Sponsor Protocol Number: 113994 Start Date*: 2010-09-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae p...
    Medical condition: Three-dose primary vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) in healthy infants between 6-14 weeks (42-104 days) of age at the time of th...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10061353 Pneumococcal infection PT
    14.0 10021881 - Infections and infestations 10061190 Haemophilus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) SE (Completed) DE (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: 2016-000274-37 Sponsor Protocol Number: PRI03C Start Date*: 2016-03-21
    Sponsor Name:MCM Vaccine B.V.
    Full Title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4- to 5 year old Children Previously Vaccinated with a 2-dose or 3-dose Infants series and Toddler dose with VAXELIS...
    Medical condition: Vaxelis is indicated for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis and invasive diseases caused by Haemophilus ...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10054187 Polio immunization LLT
    19.0 100000004865 10069543 Hemophilus influenzae type b immunization LLT
    19.0 100000004865 10069593 Pertussis immunization LLT
    19.0 100000004865 10054181 Hepatitis B immunization LLT
    19.0 100000004865 10054180 Diphtheria immunization LLT
    19.0 100000004865 10054183 Tetanus immunization LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
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