A phase III, double-blind, randomized, study in adults aged between 18 and 60 years to assess the immunological non-inferiority of two manufacturing processes of the A/California/7/2009 (H1N1)v-like antigen adjuvanted with AS03A •To evaluate the immunological non-inferiority (in terms of HI antibody GMTs) of the two H1N1 vaccines, 21d after 1st vaccination

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The vaccine response and long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) administered as one dose at 6 years post-MenC primary vaccination in healthy subjects aged 12-18 months at primary vaccination •To evaluate the immunogenicity of MenACWY-TT conjugate vaccine in terms of the percentage of subjects with an rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*. *Vaccine response to m...

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Study to evaluate the safety of Rotarix™ in Chinese children To assess the reactogenicity of a single oral dose of GSK Biologicals’ liquid HRV vaccine when compared to placebo group, in terms of solicited AEs in healthy children aged 2 to 6 years

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A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage •To demonstrate the immunological memory induced following primary vaccination in study 10PN-PD-DIT-010 (107017) and booster vaccination in study 10PN-PD-DIT-014 (107137) with the 10Pn-PD-DiT vaccine,...

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Study to evaluate immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ Inactivated Polio Vaccine (Poliorix) in healthy Chinese toddlers To assess the immunological response to a booster dose of GSK Biologicals’ IPV in terms of poliovirus type 1, 2 and 3 antibodies, one month after the booster dose in subjects primed with three doses o...

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A phase IV, open, non-randomised, multicentre study to assess the reactogenicity and immunogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus, acellular pertussis and inactivated poliovirus vaccine dTpa-IPV (Boostrix-Polio) when administered in healthy subjects aged 9-13 years, 5 years after previous booster vaccination with dTpa-IPV in the study 711866/001 (dTpa-IPV-001) To assess the incidence of grade 3 local reactions occurring during the 4-day (Day 0 - Day 3) follow-up period after administration of a booster dose of dTpa-IPV vaccine in healthy children and adoles...

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A study to evaluate reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine 444563, in healthy infants To assess the reactogenicity of GSK Biologicals’ liquid HRV vaccine when compared to placebo in terms of grade “3” solicited adverse events (AEs).

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Development of read-outs in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen (HBsAg) in combination with a GlaxoSmithKline (GSK) Biologicals’ Adjuvant System To detect and measure soluble mediators from the early immune response in plasma.

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A phase II, controlled, randomized, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly 60 years and older To assess the humoral immune response (anti-haemagglutinin) elicited by the low dose influenza vaccine adjuvanted with AS03 and by Fluarix, with the Northern Hemisphere 2006-2007 influenza vaccine com...

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A phase IIIb, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant booster administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 12-15 months of age following a 3-dose primary vaccination in study 10PN-PD-DIT-010 (107017) and to evaluate the impact of pneumococcal vaccination on nasopharyngeal carriage compared to a pneumococcal vaccine unprimed control group receiving GSK iologicals' meningococcal serogroup ACWY conjugate vaccine To determine the percentage reduction in febrile reactions (rectal temperature >=38.0°C or oral/axillary/tympanic >=37.5°C) when prophylactic antipyretic treatment is administered compared to no proph...

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