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Kusajili – Centralise les essais cliniques mondiaux
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de votre recherche par promoteur : GlaxoSmithKline Biologicals
Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A study to evaluate consistency and immunogenicity of 3 lots of GSK Biologicals’ Hib conjugate vaccine versus ActHIB and Pentacel administered at 2, 4, 6 and 15-18 months of age in healthy infants
Consistency of the immune response post-dose 3 to PRP of 3 lots of Hiberix Non-inferiority of Hiberix to ActHIB in terms of post-dose 3 anti-PRP antibody conc. >= 1.0 & 0.15 µg/mL Non-inferiority of...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase III, randomised, single-blind study to evaluate the immunogenicity and safety of sequential administration of a licensed seasonal trivalent vaccine and the pandemic H1N1 influenza candidate vaccine administered in adults 61 years or above
To assess whether vaccination with two doses of the H1N1 candidate vaccine results in an HI immune response that meets or exceeds the EMEA (CHMP) guidance targets for pandemic influenza vaccines (sero...
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Essai clos aux inclusions
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase IV, open, multicentre, multicountry study to evaluate the immune response to a challenge dose of GSK Biologicals’ Twinrix™ vaccine versus monovalent hepatitis A and B vaccines from different manufacturers in healthy and non-healthy adults aged > 41 years, approximately 48 months after primary vaccination in study 100382 (HAB-160)
To evaluate the anti-HAV and anti-HBs immune memory (in terms of anti-HAV and anti-HBs immune response elicited by the challenge dose) in a population > 41 years of age (healthy and non-healthy), appr...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase III long-term follow-up study to assess antibody persistence and immunological memory in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study 10PN-PD-DIT-001 and booster vaccination study 10PN-PD-DIT-007 and assessment of immune responses following a 2-dose catch-up immunization with GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal vaccine in the 6th year of life
•To assess the antibody persistence 1 year post booster (12 to 14 months), 2 years post booster (24 to 26 months) and 4 years post booster (48 to 50 months) following a four dose vaccination course wi...
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Essai clos aux inclusions
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Femme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
Follow-up study to evaluate the long-term immunogenicity and safety of GlaxoSmithKline Biologicals' HPV (580299) vaccine in healthy female subjects
To evaluate the long-term immunogenicity of the HPV 16/18 vaccine in serum from all subjects by enzyme-linked immunosorbent assay (ELISA) at Years 5, 6, 7, 8, 9 and 10.
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when co-administered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children
• To demonstrate that GSK Biologicals’ dTpa-IPV vaccine is non-inferior to Sanofi Pasteur MSD’s dTpa-IPV vaccine in terms of percentages of subjects with immune response to the diphtheria, tetanus and...
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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 assess the immunogenicity, safety and reactogenicity of a two-dose schedule with GSK Biologicals’ A/California/7/2009 (H1N1)v-like vaccine containing the AS03 adjuvant when co-administered with GSK Biologicals’ seasonal 2009-2010 influenza vaccine Fluarix™ either at the time of first or second vaccination in elderly subjects aged 61 years and older
•To assess whether vaccination with two doses of the H1N1 candidate vaccine results in an HI immune response to the vaccine-homologous virus that meets or exceeds the EMEA (CHMP) guidance targets for ...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
Immunogenicity and safety study of GSK Biologicals' meningococcal conjugate vaccine (GSK 134612) when co-administered with routine vaccines in healthy infants and toddlers
To demonstrate the immunogenicity of the MenACWY-TT conjugate vaccine in terms of bactericidal antibodies to N. meningitidis serogroups A, C, W-135 and Y one month post-dose 3 of MenACWY-TT at 7 month...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
The long-term antibody persistence of GSK Biologicals’ meningococcal vaccine GSK134612 in healthy toddlers
•To evaluate the long-term persistence of the immunogenicity induced by one or two doses of MenACWY-TT vaccine administered at 12 months or 9 and 12 months of age in terms of the percentage of subject...
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Femme et Homme Max 99 ans
GlaxoSmithKline Biologicals
MAJ Il y a 4 ans
A phase IIb, controlled, randomized, multicenter, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >=60 years previously vaccinated in FLU-LD-002 clinical trial
To assess in elderly subjects >=60 years old, the safety and reactogenicity of re-vaccination with the low dose adjuvanted (AS03) influenza vaccine, during the entire study period (30 days). Fluarix w...
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