- Trials with a EudraCT protocol (76)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
76 result(s) found for: Infanrix hexa AND GlaxoSmithKline Biologicals.
Displaying page 1 of 4.
| EudraCT Number: 2006-006680-23 | Sponsor Protocol Number: 109835 | Start Date*: 2007-10-16 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase III, open, randomized, controlled study to demonstrate the immunogenicity, reactogenicity and safety of GSK Biologicals meningococcal serogroup ACWY conjugate vaccine (GSK134612, MenACWY-TT... | ||
| Medical condition: One dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy children aged 12 through 23 months | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: GR (Completed) DE (Completed) AT (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2012-002426-70 | Sponsor Protocol Number: 104005 | Start Date*: 2015-06-01 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: Phase III b, open, randomised, multicenter study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated po... | ||
| Medical condition: Primary immunisation of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, polio, 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: 2004-001823-39 | Sponsor Protocol Number: 103502 | Start Date*: 2004-11-15 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly... | ||
| Medical condition: Prophylactic vaccination against pneumococcal diseases in infants and diseases caused by Neisseria meningitidis C. | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: SE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2005-003052-36 | Sponsor Protocol Number: 105555 | Start Date*: 2005-11-18 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase II, multicentre booster study to evaluate booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or to evaluate the immune memory following the administration of... | ||
| Medical condition: Booster vaccination against Streptococcus pneumoniae in healthy children having previously received vaccines as a primary 3-dose vaccination course in the study 11PN-PD-DIT-002. | ||
| Disease: | ||
| Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2009-016911-39 | Sponsor Protocol Number: 113954 | Start Date*: 2010-05-05 |
| 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 vaccine challenge in healthy children aged 11-12... | ||
| Medical condition: Antibody persistence and hepatitis B vaccine challenge at 11-12 years of age (excluding 13th birthday), after primary vaccination with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or G... | ||
| Disease: | ||
| Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | |
| Trial protocol: SK (Completed) | ||
| 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: 2006-004129-27 | Sponsor Protocol Number: X06-MMRV-302 | Start Date*: 2006-12-13 |
| Sponsor Name:Sanofi Pasteur MSD | ||
| Full Title: An open, randomised, comparative, multicentre study of the immunogenicity and safety of concomitant versus separate administration of a combined measles, mumps, rubella and varicella live vaccine (... | ||
| Medical condition: The study will involve healthy children. | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) IT (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: 2007-004002-26 | Sponsor Protocol Number: 110142, 111053 | Start Date*: 2008-03-04 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase III randomized, single-blind, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine with Pediacel™ versus co... | ||
| Medical condition: Three-dose primary vaccination of healthy infants between 6-12 weeks (42-90 days) of age at the time of the first vaccination against Streptococcus pneumoniae and booster vaccination at 11-13 month... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: NL (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2014-001120-30 | Sponsor Protocol Number: 201334 | Start Date*: 2016-05-29 |
| Sponsor Name:GlaxoSmithKline S.A. | ||
| Full Title: A phase IV, open-label, non-randomised, multi-centre study to assess the immunogenicity and safety of a booster dose of Infanrix hexa? in healthy infants born to mothers vaccinated with Boostrix? d... | ||
| Medical condition: Infanrix Hexa is indicated for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b (Hib). | ||
| Disease: | ||
| 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: 2006-000556-41 | Sponsor Protocol Number: 106789 | Start Date*: 2006-12-05 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: An open, phase IV, single-group multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in children at 4-5... | ||
| Medical condition: Antibody persistence and hepatitis B vaccine challenge in children at 4-5 years of age, previously primed and boosted with 4 doses of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine in routine vaccinatio... | ||
| Disease: | ||
| Population Age: Children, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2015-001510-10 | Sponsor Protocol Number: 109661 | Start Date*: 2015-06-17 |
| 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 Mexico 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: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: Outside EU/EEA | ||
| Trial results: View results | ||
| EudraCT Number: 2013-002821-41 | Sponsor Protocol Number: 106793 | Start Date*: 2014-01-21 | |||||||||||
| Sponsor Name:GlaxoSmithKline Biologicals | |||||||||||||
| Full Title: Persistence of hepatitis B antibodies, immunogenicity and safety of GSK Biologicals’ hepatitis B vaccine EngerixTM-B Kinder (SKF103860) challenge dose in adolescents vaccinated with four doses of I... | |||||||||||||
| Medical condition: Hepatitis B | |||||||||||||
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| Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: DE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2013-004304-19 | Sponsor Protocol Number: 117119 | Start Date*: 2015-07-23 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A Phase III, randomized, open-label, controlled, multicenter study to evaluate immunogenicity and safety of GSK Biologicals' Infanrix hexa™ vaccine when administered to healthy infants as primary v... | ||
| Medical condition: Active immunization against diphtheria, tetanus, pertussis infection caused by all known subtypes of hepatitis B virus, poliomyelitis, and invasive disease 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: 2005-004770-24 | Sponsor Protocol Number: 6096A1-006 | Start Date*: 2006-08-11 |
| Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc | ||
| Full Title: A Phase 3, Randomized, Active-controlled, Double-Blind Trial of the Safety, Tolerability and Immunologic Noninferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumoco... | ||
| Medical condition: Healthy infants | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: DE (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2015-003391-74 | Sponsor Protocol Number: 106794 | Start Date*: 2016-05-10 | |||||||||||
| Sponsor Name:GlaxoSmithKline Biologicals | |||||||||||||
| Full Title: Persistence of hepatitis B antibodies, immunogenicity and safety of GSK Biologicals’ hepatitis B vaccine, Engerix™-B Kinder (SKF103860) challenge dose, in adolescents vaccinated with four doses of ... | |||||||||||||
| Medical condition: Immunisation against infection caused by all known subtypes of hepatitis B virus. | |||||||||||||
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| Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: DE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2004-001223-37 | Sponsor Protocol Number: 102038 | Start Date*: Information not available in EudraCT |
| Sponsor Name:GlaxoSmithKline S.A. | ||
| Full Title: Ensayo clínico abierto en fase IV, para evaluar la inmunogenicidad y reactogenicidad de la vacuna combinada DTPa (Infanrix) de GlaxoSmithKline Biologicals administrada como dosis de recuerdo a los ... | ||
| Medical condition: Inmunización primaria activa frente a la difteria, tétanos y tosferina en niños, a partir de los 2 meses de edad hasta los 7 años. | ||
| Disease: | ||
| Population Age: Children, Under 18 | Gender: Male, Female | |
| Trial protocol: ES (Ongoing) | ||
| Trial results: View results | ||
| EudraCT Number: 2006-001934-42 | Sponsor Protocol Number: 107706 | Start Date*: 2006-07-26 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase IIIa open, randomised, controlled study to assess the safety, reactogenicity and immunogenicity induced by a booster dose of GlaxoSmithKline (GSK) Biologicals 10-valent pneumococcal conjuga... | ||
| Medical condition: Booster vaccination against Streptococcus pneumoniae and active immunization against measles, mumps, rubella and varicella diseases in children during the second year of life. | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: FI (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2007-000304-32 | Sponsor Protocol Number: 6096A1-3007 | Start Date*: 2007-05-28 |
| Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc | ||
| Full Title: Estudio fase 3, randomizado, controlado, doble ciego para evaluar la seguridad, tolerabilidad e inmunogenicidad de la Vacuna Neumocócica Conjugada 13-valente en niños sanos administrada con la vac... | ||
| Medical condition: Healthy infants - Niños sanos | ||
| Disease: | ||
| Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
| Trial protocol: ES (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2006-000559-16 | Sponsor Protocol Number: 107017 | Start Date*: 2006-08-09 |
| Sponsor Name:GlaxoSmithKline Biologicals | ||
| Full Title: A phase IIIb randomized, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GlaxoSmithKline ... | ||
| Medical condition: A three-dose primary vaccination of healthy infants between 9-16 weeks (63-118 days) 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: CZ (Completed) | ||
| Trial results: View results | ||
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