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Kusajili – Centralise les essais cliniques mondiaux
Résultat
de votre recherche par promoteur : GlaxoSmithKline Biologicals
Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine given as a 3-dose primary vaccination course co-administered with DTPa-HBV-IPV/Hib vaccine during the first 6 months of life and as a booster dose at 12-15 months of age
First primary objective: Non-inferiority of the candidate pneumococcal vaccine (dPly 10µg and PhtD 10µg) versus 10Pn-PD-DiT vaccine when administered with DTPa-HBV-IPV/Hib as a 3-dose primary vaccinat...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase III, open, non-randomized, trial to evaluate the immunogenicity and safety of a two-dose schedule of the A/California/7/2009 (H1N1)v-like candidate vaccine manufactured in Dresden adjuvanted with AS03A, in adults aged 18 years and above
To demonstrate that vaccination with two doses of the H1N1 candidate vaccine (A/California/7/2009 (H1N1)v-like strain) containing 1.9 µg of HA adjuvanted with AS03A results in an Haemagglutination Inh...
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unknown
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Gynaecological follow-up of a subset of HPV-015 study subjects
To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
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 16-20 months, previously primed with GSK Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine, containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD] or with GSK Biologicals licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in the primary vaccination study DTPa-HBV-IPV-116 (106786)
To assess the immunogenicty of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of persistence of the antibodies to all vaccine antigens at the time of the bo...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase III, open, multicentre, extension study to assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 10PN-PD-DIT-008 BST: 003 (106623)
•To assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine (10Pn-PD-DiT) at approximately 4 years of age in children pre...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A study to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ investigational vaccine GSK2838504A when administered to chronic obstructive pulmonary disease (COPD) patients with persistent airflow obstruction
To describe the safety and reactogenicity of the investigational vaccine
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
An open-label, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immunogenicity and safety study of a single dose hepatitis B (Engerix™-B Kinder) vaccine challenge in adolescents aged 12-13 years, previously primed and boosted in the first two years of life with four doses of GSK Biologicals’ DTPa-HBV-IPV/Hib (Infanrix™ hexa) vaccine
To assess the anti-HBs antibody response, in terms of subjects with antibody concentrations >= 100 mIU/ml, to a single challenge dose of HBV vaccine (Engerix-B Kinder) in subjects 12–13 years of age, ...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals' influenza vaccine when administered in children
•To evaluate the immunological non-inferiority (in terms of Geometric Mean Titre (GMT) and Seroconversion Rate (SCR)) of D-QIV versus TIV-1 (Fluarix) and TIV-2 in children (3 to 17 years) at 28 days (...
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase IIIb, randomized, open study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) when co-administered with GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) in healthy female subjects aged 20 to 25 years
To evaluate, one month after the third dose of hepatitis B vaccine (Month 3), the immune response against hepatitis B with respect to seroprotection rates and GMTs in both study groups.
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unknown
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
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 conjugate vaccine when co-administered with GSK Biologicals’ measles-mumps-rubella-varicella vaccine (MMRV) vaccine in children during their second year of life, previously vaccinated in infancy in the primary study 10PN-PD-DIT-001 (105553) with GSK Biologicals 10-valent pneumococcal conjugate vaccine
• To assess the incidence of post-immunization rectal fever >39.0°C following a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with the first dose of M...
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