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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, open, non-randomized study designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine H5N1 A/Vietnam/1194/2004 containing 3.8, 7.5, 15 or 30 µg HA, adjuvanted or not with AS03
To assess if the humoral immune response induced 21 days after one booster administration of the pandemic influenza vaccine fulfils the criteria established by the European Committee for Medicinal Pro...
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Essai clos aux inclusions
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Evaluation of safety and immunogenicity of a Human Papillomavirus (HPV) vaccine in human immunodeficiency virus (HIV) infected females
- To evaluate the safety and reactogenicity of both vaccines in HIV+ subjects for up to one month after the third dose of vaccine. - To demonstrate non-inferiority of Cervarix versus (vs.) Gardasil i...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
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 diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD], compared to the currently licensed GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) when administered to healthy infants at 2, 3 and 4 months of age
->To demonstrate that immunogenicity of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free formulation) in terms of antibody response to all vaccine antigens is non-inferior to DTPa-HBV-IPV/Hib vacc...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Immunogenicity, safety and reactogenicity study of GlaxoSmithKline (GSK) Biologicals’ Hib-MenCY-TT vaccine compared to monovalent Hib vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age
1.To demonstrate the lot-to-lot consistency of 3 lots of Hib-MenCY-TT in terms of immunogenicity for PRP by ELISA and MenC and MenY by hSBA. 2.To demonstrate non-inferiority of PRP after a fourth dos...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ / Influsplit SSW® 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years)
To evaluate the humoral response (anti-hemagglutinin antibody tested by hemagglutination inhibition) against each vaccine strain in adults aged 18 years or above, 21 days after vaccination with Fluari...
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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 GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing vaccine formulations when administered according to a 0-2-6 month schedule, in healthy children aged 12-23 months at the time of first vaccination
• To compare the two formulations of GSK Biologicals’ S. pneumoniae protein containing vaccine combined with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (pooled groups) versus GSK Biolog...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Study to compare the immunogenicity, safety and reactogenicity of SmithKline Beecham’s Twinrix administered following a 2 dose schedule (0, 6 months) to that of Twinrix Junior administered following a 3 dose schedule (0, 1, 6 months) in healthy volunteers aged 12-15 years
For primary study: To demonstrate, that the immunogenicity elicited by the combined hepatitis A / hepatitis B vaccine Twin-rix is at least equivalent to that of Twinrix Junior vaccine, by measuring t...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Study to evaluate immunogenicity, reactogenicity and safety of Rotarix™ vaccine in Korean infants
To demonstrate at least 40% increase in seroconversion rate, in the HRV vaccine group at Visit 3 (i.e. one month post-Dose 2) as compared to Placebo group. Criteria: the primary objective was met if ...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals’ herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects
•To evaluate the safety and reactogenicity of the gE/AS01B study vaccine in HIV-infected subjects, by ART (antiretroviral therapy) ART and CD4 count cohorts, and overall (ART/CD4/overall) •To estimate...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Phase III, non-randomised, open-label study to evaluate the safety and immunogenicity of a prime-boost schedule of the H1N1 candidate vaccine adjuvanted with AS03B administered to subjects aged 3 to 17 years
To evaluate the humoral immune response after two primary administrations of the candidate H1N1 pandemic vaccine that meets or exceeds the EMEA (CHMP) guidance targets for pandemic vaccine seroconvers...
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