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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
Evaluation of the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) when co-administered with Pneumovax™ 23 in adults 50 years of age and older
1) To demonstrate the non-inferiority of the immune response to D-QIV (FLU D-QIV) in terms of HI antibody titres at Day 28 after D-QIV vaccination, for each influenza virus strain, when co-administere...
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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
An open, multicentric, post-marketing surveillance (PMS) study to assess the safety and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-IPV/Hib vaccine administered at 3, 4, 5 and 18 months of age, in healthy infants
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine.
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Safety and immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (GSK-580299) in healthy female children 4-6 years old
Safety •To assess the safety, reactogenicity and occurrence of clinically relevant abnormalities in biochemistry and haematology parameters after administration of the HPV-16/18 L1 VLP AS04 vaccine a...
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ inactivated hepatitis A and hepatitis B vaccine adsorbed (Twinrix® Paediatric) in healthy female subjects aged 9–15 years
•To demonstrate non-inferiority of the hepatitis A immune response when HAB is co-administered with HPV-16/18 vaccine at Month 0, 1 and 6 compared to when HAB is administered alone at Month 0, 1 and 6...
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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 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158)
• To assess antibody persistence against N. meningitidis serogroups (SP) A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years ea...
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alternative dosing schedule at 0, 1 and 12 months as compared to the standard dosing schedule at 0, 1 and 6 months in young healthy female subjects aged 15-25 years
To demonstrate that the immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to an alternative schedule of 0, 1, 12 months is non-inferior to that of the vaccine adm...
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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
An open single centre study to evaluate the long-term antibody persistence and immune memory between 16 and 20 years after the primary study HAB-032 (208127/022) in which healthy adults were vaccinated with Twinrix™ Adult following a three-dose schedule
To evaluate anti-HAV and anti-HBs antibody persistence at Years 16, 17, 18, 19 and 20 after a three-dose primary vaccination course with Twinrix Adult.
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Evaluation of a new vaccine treatment for patients with metastatic skin cancer
Co-primary objectives of the Phase I segment: To characterize •The occurrence of dose-limiting toxicity. •The anti-PRAME humoral immune response Co-primary objectives of Phase II segment: To char...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
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 years of age, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine
To assess the anti-HBs antibody response to a challenge dose of HBV vaccine (Engerix-B Kinder) in subjects at 4-5 years of age, previously vaccinated with four doses of Infanrix hexa in the first two ...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Immunogenicity and safety study of booster dose of GSK Biologicals’ IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) vaccine
•To assess the persistence of antibodies to all vaccine antigens before the booster dose. •To assess the immune response to the study vaccines in terms of seroprotection to diphtheria, tetanus, Haemo...
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