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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
Immunogenicity and safety study of GSK Biologicals’ Infanrix-IPV+Hib™ vaccine
To demonstrate that the immunogenicity of GSK Biologicals’ DTPa-IPV/Hib vaccine administered at 2, 3 and 4 months of age (Group A) is non-inferior to that of the concomitant administration of GSK Biol...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Immunogenicity and safety of BoostrixTM using a new syringe in 10 to 15-year-old adolescents
To demonstrate that Boostrix administered using the new syringe presentation is non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to all vaccin...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Safety and Immunogenicity of Novartis Meningococcal Group B Vaccine When Administered Concomitantly With Novartis MenACWY Conjugate Vaccine to Healthy Infants
• To assess immunological non-inferiority of rMenB+OMV NZ and MenACWY when concomitantly administered compared to either alone in healthy infants at 3, 5, 7 and 13 months of age, as measured by the ra...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ quadrivalent influenza candidate vaccine GSK2321138A (FLU D-QIV), when administered to children 18 to 47 months of age
• To assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the quadrivalent influ-enza study vaccine (FLU D-QIV) compared to the trivalent influenza vaccine (Fluarix™) i...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase II, observer-blind, randomised, placebo-controlled, adjuvant-dose selection, multicenter prophylactic vaccination study to evaluate the immunogenicity and safety of GSK Biologicals’ herpes zoster vaccine, gE/AS01B, in comparison to gE combined with ½ dose AS01B adjuvant (gE/AS01E), to unadjuvanted gE (gE/Saline), and to Saline (placebo) when administered twice in subjects aged 50 years and older
To compare gE and VZV-specific CD4 T cell-mediated immune (CMI) and humoral immune responses to study vaccines (gE/AS01B, gE/AS01E, and gE/Saline) at Month 3 (one month following vaccinations at Month...
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Essai clos aux inclusions
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 18 – 25 years and to demonstrate non-inferiority of the candidate HPV vaccine manufactured at 600L scale compared with a lower (80L) manufacturing scale
First primary objective: •To demonstrate lot-to-lot consistency in terms of immunogenicity between three consecutive industrial production lots (600L scale) of the HPV-16/18 VLP/AS04 vaccine one mon...
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase II, single-blind, randomized, controlled, multicentre vaccination study to evaluate the safety and immune response of the GSK Biologicals Zoster vaccine, gE/AS01B, and to compare 3 doses of gE with AS01B adjuvant in healthy elderly subjects, aged 60 to 69 years and 70 years and above
The main objective of the trial is to compare the CD4 T cell response to gE of gE/AS01B study vaccines at Month 3 in healthy elderly subjects of more than or equal to 70 years of age (YOA).
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Immunogenicity and safety study of GSK Biologicals’ Infanrix hexa™ when administered in healthy infants at 2, 4 and 6 months of age
To demonstrate the non-inferiority of Infanrix hexa to Pediarix co-administered with ActHIB, in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens [pertussis toxoid (PT), fi...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Consistency, immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults ≥ 50 years of age
- To demonstrate lot-to-lot consistency in terms of anti-gE humoral immunogenicity between three production lots of the HZ/su vaccine one month after the second dose (Month 3).
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine and to evaluate the liquid formulation as compared to the lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose primary vaccination in healthy infants previously uninfected with HRV
•To demonstrate the lot-to-lot consistency of the liquid formulation of GSK Biologicals’ HRV vaccine in terms of immunogenicity as measured by serum anti-rotavirus IgA antibody levels one month after ...
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