A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influspit SSW®) 2006/2007 in people aged 18 years or above To evaluate the humoral response (anti-haemagglutinin antibody tested by haemagglutination inhibition) against each vaccine strain in adults aged 18 years or above 21 days after vaccination with Fluar...

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Study to evaluate the immunogenicity, safety, and reactogenicity of TWINRIX ADULT containing 720 ELISA units of hepatitis A antigen and 20 μg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years To evaluate anti-HAV and anti-HBs antibody persistence at Year 6 (i.e. Month 72), Year 7 (i.e. Month 84), Year 8 (i.e. Month 96), Year 9 (i.e. Month 108) and Year 10 (i.e. Month 120) after the first v...

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A phase III, observer-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological equivalence of the Quebec-manufactured A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A as compared to the Dresden-manufactured A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A To assess the immunological equivalence (in terms of vaccine-homologous virus H1N1 HI antibody GMTs) of the Quebec-manufactured A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03A and the D...

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A study to rank different dosages of antigen of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccine (GSK3003891A), based on their immune response and safety, when administered to healthy adult women To rank different formulations of the investigational RSV vaccine based on safety/reactogenicity and immunogenicity data up to 1 month post-vaccination (Day 30).

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Evaluation of the safety and immunogenicity of GlaxoSmithKline Biologicals’ HPV vaccine 580299 when administered in healthy females aged 9 - 25 years using an alternative schedule and an alternative dosing as compared to the standard schedule and dosing To evaluate the immunogenicity of the HPV-16/18 L1 VLP AS04 vaccine one month after the last dose when administered at different dosages (20 or 40 µg of each HPV antigen) and on different schedules (0...

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A study to compare the immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose presentation to the licensed 1-dose Synflorix™ (10Pn-PD-DiT) vaccine when co-administered with DTPw-combination vaccine in healthy infants To demonstrate the non-inferiority of GSK Biologicals’ 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of the immune response to the 10 vacc...

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Safety and immunogenicity of GSK Biologicals’ (pre-) pandemic influenza vaccine in children aged 6 to 35 months To assess whether a heterologous booster dose of 1.9 µg A/turkey/Turkey/1/2005 (H5N1) HA with AS03B given 6 months following a 2-dose primary vaccination series with 1.9 µg A/Indonesia/05/2005 (H5N1) ...

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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-028 (208127/021) 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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A phase IIb, open, randomized, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Meningitec™ or Mencevax™ ACWY to healthy subjects aged 1 through 10 years of age One month after vaccination: For Subjects of two years of age and above • To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine compared to the licensed Mencevax ACWY in terms of the vac...

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A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine given at 12-15 months of age to subjects who were primed in primary study 103974 (HIB-MENC-TT-012) and boosted in study 104056 (HIB-MENC-TT-013 BST:012) In all evaluable subjects of groups HibMenC and LicMenC at 12 months after the booster vaccination; in all evaluable subjects of groups HibMenC and LicMenC at 24 months after the booster vaccination; ...

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