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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
Study to evaluate the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
•In all subjects, to determine if two doses of GSK Biologicals’ HRV vaccine given concomitantly with routine vaccinations* can prevent severe rotavirus gastroenteritis (RV GE) caused by the circulatin...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of four different formulations of GlaxoSmithKline (GSK) Biologicals’ new generations meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old
Based on the immune response induced one month post vaccination, to select the best of four different formulations of GSK Biologicals’ new generations MenACWY-TT conjugate vaccine when given as one si...
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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, controlled study to assess in a double blind manner the lot-to-lot consistency of three consecutive production lots of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine and to evaluate the non-inferiority to Prevenar™ in a single blind design, when administered as a 3-dose primary immunization course before 6 months of age
To demonstrate the lot-to-lot consistency of three consecutive production lots of the GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in terms of the immune response induced against each of ...
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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' Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) Influsplit Tetra (Fluarix Tetra) (2013/2014 season) in adults 18 years of age and older
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 aft...
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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 AS04 vaccine co-administered with GlaxoSmithKline Biologicals’ combined reduced-antigen diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (Boostrix® Polio) in healthy female subjects aged 10–18 years
• To demonstrate non-inferiority of the dTpa-IPV immune response at Month 1 when dTpa-IPV is co-administered with HPV-16/18 L1 AS04 vaccine at Month 0 compared to when dTpa-IPV is administered alone a...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase II, open, randomised, comparative study to evaluate the immunogenicity and safety of GlaxoSmithKline's (GSK) Biologicals' measles-mumps-rubella-varicella candidate vaccine (MeMuRu-OKA) and GSK Biologicals' measles-mumps-rubella vaccine (Priorix) co-administered in separate injections with GSK Biologicals' varicella vaccine (Varilrix) when given in healthy children who previously received a first dose of an MMR vaccine
• To demonstrate the non-inferiority of MeMuRu-OKA vaccine to Priorix and Varilrix vaccines administered as separate injections in terms of varicella seroconversion rate 42-56 days after the first vac...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Study to evaluate immunogenicity and safety of GSK Biologicals’ measles, mumps, rubella and varicella (MMRV) freezer-stored (MMRVF) & refrigerator-stored (MMRVR) vaccine formulations vs. ProQuad in infants 12-14 months of age when co-administered with hepatitis A and pneumococcal conjugate vaccines
• To demonstrate the non-inferiority of GSK Biologicals’ MMRVR co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to - the seroresponse rate ...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
A phase III open (partially double-blind), controlled, multicenter, multicountry primary & booster vaccination study to demonstrate the non-inferiority of the meningococcal serogroup C response of GlaxoSmithKline Biologicals’ Hib-MenC vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and immunogenicity of Hib-MenC when given as a booster dose at 12-15 months of age
The co-primary objectives of the primary & booster phases will be assessed in a sequential fashion: One month after the primary vaccination course, to demonstrate the non-inferiority of the -meningoco...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
An open, randomized phase I/II study to demonstrate the non inferiority in term of cellular mediated immune response between GlaxoSmithKline Biologicals influenza candidate vaccines containing various adjuvants administered in elderly population (aged 65 years and older) and Fluarix™ (known as alpha-Rix™ in Belgium) administered in adults (18-40 years)
To demonstrate the non inferiority 21 days post-vaccination between the influenza adjuvanted vaccines administrated in elderly subjects (aged 65 years and older) and Fluarix™ administered in adults (a...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 5 ans
Long-term persistence of hepatitis B antibodies and immune response to a challenge dose of GSK Biologicals’ HBV vaccine, Engerix™-B Kinder (SKF103860), in 15-16 years old adolescents, vaccinated in infancy with Engerix™-B Kinder
To assess the anti-HBs antibody response to a challenge dose of Engerix-B Kinder in subjects 15-16 years of age vaccinated with three doses of Engerix-B Kinder in infancy.
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