- Trials with a EudraCT protocol (78)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
78 result(s) found for: Infanrix hexa AND GlaxoSmithKline Biologicals.
Displaying page 2 of 4.
| EudraCT Number: 2004-000397-31 | Sponsor Protocol Number: 6106A1-500 | Start Date*: 2005-05-09 |
| Sponsor Name:Wyeth Vaccines Research | ||
| Full Title: A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Admini... | ||
| Medical condition: Healthy infants who shall receive their first routine vaccination. | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| 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: 2005-003437-41 | Sponsor Protocol Number: 105539 | Start Date*: 2005-11-25 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according... | ||
| Medical condition: A 2-4-11 month vaccination schedule of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, co-administered with DTPa combined vaccines in healthy infants between 8-16 weeks of age at the tim... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: SE (Completed) DK (Completed) SK (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2006-000549-20 | Sponsor Protocol Number: 106744 | Start Date*: 2006-07-20 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 7 to 9 year... | ||
| Medical condition: Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine or with GSK Biologicals’ HBV vaccine, given as a three dose primary vaccination series in the first year of life, followe... | ||
| Disease: | ||
| Population Age: Children, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2006-000560-93 | Sponsor Protocol Number: 106623 | Start Date*: 2006-06-27 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase IIIa, open, multicentre study to evaluate the immunological memory induced in healthy children following a 3-dose primary vaccination with either GSK Biologicals’ 10-valent pneumococcal con... | ||
| Medical condition: A single dose of Sanofi Pasteur MSD’s unconjugated 23-valent polysaccharide pneumococcal vaccine (Pneumovax™23) to healthy children who were previously primed with the full three doses of GSK Biolo... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (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 | ||
| EudraCT Number: 2010-019253-18 | Sponsor Protocol Number: 113978 | Start Date*: Information not available in EudraCT |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase II, open-label, multicentre study to evaluate the safety and immunogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib-MenC-TT vaccine as a booster dose in children aged 12 to 18 months, previous... | ||
| Medical condition: Booster immunization of healthy children in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and serogroup C meningoco... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: PL (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2005-003300-11 | Sponsor Protocol Number: 105553 | Start Date*: 2005-11-25 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase III randomised, controlled study to assess in a double blind manner the lot-to-lot consistency of three consecutive production lots of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococ... | ||
| Medical condition: Three dose primary vaccination of healthy infants between 6 and 12 weeks of age at the time of the first vaccination against Streptococcus pneumaniae | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: FI (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2010-022538-10 | Sponsor Protocol Number: 112688 | Start Date*: 2011-04-05 | |||||||||||
| Sponsor Name:GlaxoSmithKline Biologicals | |||||||||||||
| Full Title: An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (Engerix-B™ Kinder) vaccine challenge in children... | |||||||||||||
| Medical condition: Antibody persistence and hepatitis B vaccine challenge in children aged 7–8 years, previously primed and boosted with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) as part of... | |||||||||||||
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| Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: DE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2006-005733-38 | Sponsor Protocol Number: 109507 | Start Date*: 2007-04-13 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase III, open, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as ... | ||
| Medical condition: Booster vaccination against Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type b in healthy infants 11 to18 months of age who were previously primed with three doses o... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) ES (Completed) PL (Completed) | ||
| Trial results: View results | ||
| 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: 2006-001481-17 | Sponsor Protocol Number: 107137 | Start Date*: 2007-05-22 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK... | ||
| Medical condition: A single dose booster vaccination against Streptococcus pneumoniae of healthy children between 12-15 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: CZ (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2005-003299-40 | Sponsor Protocol Number: 105554 | Start Date*: 2005-10-18 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase IIIa randomized, controlled study to assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered as a 3-dose primary immuniza... | ||
| Medical condition: Three dose vaccination of healthy infants between 8-16 weeks of age at the time of the first vaccination against Streptococcus pneumoniae. | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2006-000553-22 | Sponsor Protocol Number: 106745 | Start Date*: 2006-05-24 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 4-6 years o... | ||
| Medical condition: Four dose vaccination course with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine, given as a three-dose primary vaccination series in the first year of life, followed by a booster in the second year of ... | ||
| Disease: | ||
| Population Age: Children, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2013-003427-10 | Sponsor Protocol Number: 111157 | Start Date*: 2015-05-04 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase III, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) administered to I... | ||
| Medical condition: Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Hib 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: 2006-000898-30 | Sponsor Protocol Number: A5I19 | Start Date*: 2006-07-05 |
| Sponsor Name:Sanofi Pasteur Incorporated | ||
| Full Title: Safety and Immunogenicity of Booster Vaccination with PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conj... | ||
| Medical condition: PEDIACEL is a fully liquid combination vaccine indicated for infants and children for the prevention of five infectious diseases (diphtheria, tetanus, pertussis, poliomyelitis and infections caused... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| 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: 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: 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 ... | ||||||||||||||||||||||||||||||||||||||
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| Population Age: Children, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||||||||||||
| Trial protocol: FI (Completed) | ||||||||||||||||||||||||||||||||||||||
| Trial results: View results | ||||||||||||||||||||||||||||||||||||||
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