Influenza vaccine (split virion, inactivated) has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Influenza vaccine (split virion, inactivated) studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
107564 IV An observational study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly. Fluarix™ (Flu): GlaxoSmithKline (GSK) Biologicals’ trivalent inactivated split virion influenza vaccine.
106252 (Flu-062) IV An open, phase IV study on the immunogenicity and tolerability of Influsplit SSW® 2005/2006 in children aged 6-13 years.
108134 (Fluarix US-006) IV A randomized, double-blind, placebo-controlled, multi-country and multi-center, phase IV study to demonstrate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in adults. Fluarix™ (Flu): GlaxoSmithKline Biologicals’ licensed influenza vaccine.
218352/044 (Flu-044) IV Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 2000/2001 in children aged from 6 months to < 6 years.
218352-052 (influ 02/2002, FLU-052) IV Open, multicentric, randomized, compared vaccination study (phase IV) to evaluate the non-inferiority of the influenza-vaccine Influsplit SSW®/Fluarix™ 2002/2003 versus the adjuvanted influenza-vaccines Fluad® 2002/2003 and Inflexal V® 2002/2003 concerning immunogenicity and reactogenicity in subjects aged over 60 years.
684289/001 IV A phase IV, open, randomised study in adults aged 18-60 and over 60 years to evaluate the immunogenicity and the reactogenicity of GlaxoSmithKline Biologicals Fluarix™ vaccine administered using two different routes.
100349-054 III A phase III double-blind randomized multicentric study to determine the immunogenicity and reactogenicity of an investigational influenza vaccine formulation I compared to the standard influenza vaccine of GlaxoSmithKline Biologicals’ Influsplit SSW®/ Fluarix™ 2003/2004 and compared to an investigational influenza vaccine formulation II in subjects aged over 18 years.
100350-055 III A phase III double-blind randomized multicentric study to determine the reactogenicity of an investigational influenza vaccine compared to the standard influenza vaccine of GlaxoSmithKline Biologicals’ Influsplit SSW®/ Fluarix™ 2003/2004 in subjects aged over 18 years.
100351-056 III A phase III double-blind randomized multicentric study to determine the immunogenicity and reactogenicity of an investigational trivalent influenza split vaccine 2003/2004 or of GlaxoSmithKline Biologicals’ standard formulation Influsplit SSW®/ Fluarix™ 2003/2004 in children aged from 6 months until 6 years.
102151 (Flu-058) III Open immunization study to determine the reactogenicity and immunogenicity of Fluarix™/Influsplit SSW® 2004/2005 in persons as of 18 years of age.
102500-060 III Double-blind randomised, multicentre, comparative phase III vaccination study to determine the immunogenicity and reactogenicity of an investigational influenza vaccine formulation versus the standard formulation of Influsplit SSW® 2004/2005 in subjects at least 18 years old.
104233 (Fluarix-US-001) III A randomized, double-blinded, placebo-controlled, phase III study to evaluate the immunogenicity and safety of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in healthy adults
104437 (Fluarix-US-003) III A phase III, observer-blind, randomized study to evaluate the immunogenicity and safety of Fluarix™ (GlaxoSmithKline Biologicals) compared with Fluzone® (Aventis Pasteur) administered intramuscularly in adults 18 years and older in the U.S. Fluarix™: GlaxoSmithKline Biologicals’ inactivated influenza split vaccine, referred to as Flu Group. Fluzone®: Sanofi Pasteur (formerly Aventis Pasteur) US-licensed influenza vaccine, referred to as Control Group.
104438 (Flu-US-004) III A randomized, double-blind, placebo-controlled, post-marketing, phase III study to evaluate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in adults. Fluarix™: GSK Biologicals’ influenza vaccine (Flu)
104745 (Flu-061) III Open immunization study to determine the reactogenicity and immunogenicity of Fluarix™ / Influsplit SSW® 2005/2006 in persons as of 18 years of age.
104888 & 107509 III A phase II/III, observer-blind, multicountry, multicentre, randomized study to demonstrate the superiority in terms of immunogenicity of an investigational vaccination regimen administered in adults aged 50 years and older compared to Fluarix™. Fluarix™ (Flu): GlaxoSmithKline Biologicals’ licensed influenza vaccine.
107064-107217 III A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of an investigational vaccination regimen in adults aged 18 years and older.
107507 (Flu-063) III A Phase III study for evaluation of immunogenicity and reactogenicity of Fluarix™ (Influsplit SSW®) 2006/2007 in people aged 18 years or above Influsplit SSW® 2006/2007 (Fluarix™): GSK Biologicals’ inactivated influenza split vaccine
110221 (Fluarix-064 PRI) III A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ (Influsplit SSW®) 2007/2008 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Fluarix™ (Influsplit SSW®) 2007/2008: GSK Biologicals’ inactivated influenza split vaccine
218352/040 (Flu-040) III Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 1999/2000 (preservative-free) in persons as of 18 years of age.
218352/047 (Flu-047) III Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 2001/2002 / Fluarix™ 2001/2002 in persons as of 18 years of age
218352/048 (Flu-048) III Immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 2001/2002 (preservative-free) in persons as of 18 years of age.
218352/049 (Flu-049) III Immunization study to determine the reactogenicity and safety of Influsplit SSW® 2001/2002 (preservative-free) in persons as of 18 years of age
218352/051 (Flu-051) III Open immunization study to determine the reactogenicity and immunogenicity of Influsplit SSW® 2002/2003 in persons as of 18 years of age
701464/005 III A phase III, open, controlled, randomised study in adults aged 18-60 and elderly aged over 60 years to confirm the immunogenicity and the reactogenicity of GlaxoSmithKline Biologicals investigational influenza vaccine.
104887 II A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of an investigational vaccination regimen in elderly adults (= 66 years) previously vaccinated with the same investigational vaccination regimen. Fluarix™ (known as a-Rix™ in Belgium) administered in young (19-41 years) and elderly (= 66 years) adults will be used as reference. Fluarix™ (Flu): GlaxoSmithKline Biologicals’ licensed trivalent split influenza vaccine.
106622 II An observational study to investigate the incidence of influenza, downstream complications of influenza and hospitalizations, in elderly subjects vaccinated with GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly. Fluarix™ (Flu): GlaxoSmithKline (GSK) Biologicals’ inactivated influenza split vaccine.
107973 II A phase II, open, controlled study to evaluate the reactogenicity and the immunogenicity of an investigational vaccination regimen in elderly adults (>/ 67 years) previously vaccinated with the same investigational vaccination regimen. Fluarix™ (known as a-Rix™ in Belgium) will be used as a reference. Fluarix™ (Flu): GSK Biologicals’ licensed influenza vaccine.
107975 II A phase II, controlled, randomized, single blind study to evaluate the immunogenicity, safety and reactogenicity of an investigational vaccination regimen compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >/60 years. Fluarix™ (Flu): GlaxoSmithKline Biologicals’ inactivated influenza split vaccine.
108656 II A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of an investigational vaccination regimen compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old. Fluarix™: GlaxoSmithKline Biologicals’ licensed influenza vaccine (Flu vaccine)
108708 II A phase IIb, controlled, randomized, multicenter, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of an investigational vaccination regimen compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly = 60 years previously vaccinated in clinical trial 107192. Fluarix™ (Flu): GlaxoSmithKline (GSK) Biologicals’ inactivated influenza split vaccine.
104540/002 II A phase I/II, open, controlled study in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals’ influenza candidate vaccine in an elderly population aged over 65 years (> 65 years old) previously vaccinated in 2004 with the same candidate vaccine in a previous clinical trial. For immunogenicity and safety evaluations, Fluarix™ (known as a-Rix™ in Belgium) vaccine will be used as reference. Fluarix: Commercially available influenza vaccine
107022 & 107191 II A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the non-inferiority of an investigational vaccination regimen compared with Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly = 60 years. Fluarix™ (Flu): GlaxoSmithKline Biologicals’ inactivated influenza split vaccine.
107192 & 107214 II A phase IIb, controlled, randomised, multicenter, observer blinded study to evaluate the immunogenicity and safety of investigational vaccination regimens compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in elderly = 60 years. Fluarix™ (Flu): GlaxoSmithKline Biologicals’ inactivated influenza split vaccine
218352-053 II Double-blind, randomized, multicentric, compared vaccination study to evaluate the immunogenicity and reactogenicity in subjects aged over 18 years of an influenza split vaccine 2002/2003, standard formulation, versus an investigational influenza split vaccine.
104886 I An open, randomized phase I/II study to demonstrate the non inferiority in terms of cellular mediated immune response of an investigational vaccination regimen administered in elderly population (aged 65 years and older) as compared to Fluarix™ (known as a-Rix™ in Belgium) administered in adults (18-40 years). Fluarix™ (a-Rix™): GlaxoSmithKline Biologicals’ licensed influenza vaccine
102396/002 I A phase I/II, open, controlled study in order to evaluate the reactogenicity and the immunogenicity of the GlaxoSmithKline Biologicals experimental influenza vaccine in an elderly population aged over 65 years (> 65 years-old) and previously vaccinated in 2003 with the experimental influenza vaccine in the Explo-Flu-001 clinical trial. For immunogenicity and safety evaluations, Fluarix™ vaccine (known as a-rix™ in Belgium) will be used as reference.
103304-001 I A phase I, open, randomised, controlled study in an elderly population aged over 65 years (≥ 65 years-old) in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals’ experimental Influenza vaccines, administered intramuscularly as compared to Fluarix™ vaccine (known as a-Rix™ in Belgium).
104440-002 I A phase I, open, randomised study in adults aged between 18 and 45 years to evaluate the reactogenicity and the immunogenicity of an experimental administration of GlaxoSmithKline Biologicals Fluarix™ vaccine (known as a-Rix™ in Belgium). Standard intramuscular and subcutaneous vaccine administration will be used as references.
227855/001 I A phase I, open, randomised study in an elderly population aged over 65 years in order to evaluate the reactogenicity and the immunogenicity of GlaxoSmithKline Biologicals experimental Influenza vaccine or a Whole virus vaccine. For both immunogenicity and safety evaluations, the commercial inactivated split vaccine (Fluarix™) will be used as reference.