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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 4 ans
A phase II, controlled, single centre, open study to evaluate the safety, reactogenicity and immunogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with a reduced dose of AS03, compared to a second dose of Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects 18-60 years previously vaccinated in FLU-LD-004 clinical trial
To assess during the entire study period (30 days) the safety and reactogenicity of re-vaccination with the low dose influenza vaccine adjuvanted with half dose of AS03. Fluarix™ will be used as refer...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks
To evaluate the safety and reactogenicity of the H1N1 candidate vaccine in terms of solicited local and general symptoms, unsolicited adverse events (AEs) and serious adverse events (SAEs) two weeks p...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
Immunization of infants 6-14 weeks of age, with GlaxoSmithKline Biologicals’ Rotavirus vaccine to explore the existence of transmission of rotavirus vaccine strain between twins in a family
Estimate the rate of transmission of the HRV vaccine strain to twin receiving placebo using RV detection by ELISA and vaccine strain identification using appropriate molecular technique.
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ meningococcal vaccine with or without co-administration of a licensed viral vaccine and Boostrix in female adolescents and young adults
•To demonstrate non-inferiority of MenACWY-TT co-ad with a viral vaccine compared to MenACWY-TT alone with respect to GMTs for A, C, W-135 and Y. •To demonstrate the non-inferiority of a viral vacci...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase III open study to assess the safety, reactogenicity and immunogenicity following booster administration of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine, co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) vaccine in preterm born children at 16-18 months of age following primary immunisation in study 10PN-PD-DIT-015 (107737)
To evaluate the safety and reactogenicity of a booster dose of GSK Biologicals´ 10-valent pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib vaccine in preterm born chi...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase III, open, randomized, controlled, primary vaccination study to demonstrate non-inferiority of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY conjugate vaccine compared to licensed MenC-CRM197 conjugate vaccine when administered to healthy subjects aged 2 through 10 years
One month after vaccination: •To demonstrate non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed conjugate vaccine (MenC-CRM197) in terms of serum bactericidal antibody vacci...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ MMRV vaccine (Priorix-Tetra™) in healthy 12 to 23-month-old children
42 days after the first vaccine dose •To demonstrate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to Meningitec, the licensed conjugate vaccine for N. meningitidis serogroup C...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A study for evaluation of immunogenicity and reactogenicity of Fluarix/Influsplit SSW 2012/2013 in people aged 18 years and above
To evaluate the humoral response (anti-haemagglutinin [HA] antibodies tested by Haemagglutination Inhibition [HI]) against each vaccine strain in adults 18-60 years and >60 years of age, 21 days after...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine adjuvanted with AS03 and the monovalent A/California/7/2009 (H1N1)v-like candidate vaccine formulated without adjuvant in subjects aged 10 to less than 18 years
To assess whether vaccination with monovalent A/California/7/2009 (H1N1)v-like vaccine (each treatment group) results in an immune response to the vaccine-homologous virus that meets or exceeds the CH...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
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 aged 7–8 years, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine
•To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects 7–8 years of age, previously vaccinated with four doses of Infanrix hexa in the first two ye...
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