Influenza Vaccine, Fluarix
Background: The trivalent inactivated split-influenza vaccine, Fluarix has been available since 1992.
Aim: To assess the safety and immunogenicity of the vaccine from studies in healthy adults and the elderly performed from 1992 to 2001 to comply with European Union registration requirements, and from studies in children and populations at high risk of severe influenza illness or influenza-related complications.
Methods: Annual registration studies were performed in healthy adults aged 18-60 years and the elderly aged >60 years. Six studies in children aged 6 months years, and five studies in adults with high-risk conditions, were done during the same period. The high-risk populations included immunosuppressed patients with solid tumours or systemic malignancies, renal or liver transplant recipients, and patients with chronic obstructive pulmonary disease or insulin-dependent diabetes mellitus. Adults and children aged >36 months received 0.5ml of the vaccine by intramuscular or deep subcutaneous injection. Children aged 6-35 months received 0.25ml; in some children not previously vaccinated or exposed to influenza, a second dose was given 4 weeks later. Immunogenicity was determined by measuring haemagglutination inhibiting antibodies just before and 21 ± 2 days after vaccination. Redness, swelling, induration and pain at the injection site were recorded, along with systemic symptoms such as fever.
Results: In all registration studies (n = 1 558), the vaccine consistently exceeded European Union immunogenicity criteria. Geometric mean titres in adults peaked 21 days after vaccination and remained above the protection level for all three strains for up to 12 months. In healthy adults and the elderly, seroprotection rates were 69-100% and consistently exceeded 82% from 1996. Immunogenicity in children (n = 364) and high-risk populations (n = 285) exceeded the targets for healthy adults. The vaccine was well tolerated in all age groups and populations. The most frequently reported symptoms in healthy adults and the elderly were local redness of >20mm (10-31%) and swelling of >20mm (11-16%). The incidence of fever >38.5°C was in healthy adults and high-risk groups; fever of >37°C was also rare (0-5%) in children over 6 years old, but was more frequent in younger children (11-27%). The reactogenicity of the vaccine was low in the high-risk populations.
Conclusions: Fluarix has a good safety profile and is highly immunogenic in all age groups as well as in high-risk populations. The all-year persistence of antibodies means that the vaccine gives protection for the entire influenza season.
Influenza is a highly contagious febrile illness caused by infection of the respiratory tract by influenza viruses A and B. The infection is transmitted via respiratory secretions expelled during sneezing or coughing. Influenza epidemics usually occur every year, almost exclusively during the winter months in temperate climates: October to April in the northern hemisphere and May to September in the southern hemisphere. However, influenza activity occurs throughout the year in tropical regions. In a typical epidemic, 5-15% of the general population can become infected. Annual epidemics occur because the virus can mutate quickly, often producing new strains with minor changes in their surface antigenic glycoproteins (antigenic drift), against which humans have incomplete immunity. Both influenza A and influenza B can cause epidemics.
Occasionally viruses undergo major antigenic changes (antigenic shift) and these can cause influenza epidemics worldwide - pandemics. In the past, pandemics have been caused by influenza A viruses only. The lack of immunity against the 'new' virus makes large sections of the population particularly susceptible to severe disease and increased mortality. The great 'Spanish flu' pandemic in 1918-1920 killed 20-50 million people worldwide, mainly those aged 20-40 years.
Those that become infected with the virus may be asymptomatic, but at worst the infection may lead to a severe respiratory tract illness, with systemic symptoms affecting a wide range of organs, and eventually death. In most people with no chronic illness, symptoms include fever, unproductive cough, sore throat, runny or stuffy nose, headache, muscle aches, loss of appetite and often extreme fatigue. Most people usually recover within 1-2 weeks from the onset of symptoms.
Compared with the effect it has on healthy adults, influenza can cause a more serious illness and greater mortality in groups such as the very young or elderly, the immunocompromised, and those with chronic diseases including chronic obstructive pulmonary disease (COPD), asthma, cardiovascular disease and diabetes. These groups are considered to be at high risk, because influenza may exacerbate their underlying disease or predispose them to secondary complications such as pneumonia or bacterial infections. During the 1978-1981 influenza epidemics in Houston, the highest hospitalisation rates due to acute respiratory illness were 197/100 000 for those considered to be at high risk of developing influenza-related complications compared with 93/100 000 for those at 'normal' risk. Estimates of influenza and pneumonia deaths per 100 000 individuals range from 2 for 45-64-year-olds without chronic disease to 797 for those aged over 65 years with two or more high-risk conditions. During influenza epidemics, 80-90% of excess deaths occur among those over 65 years old.
The effective management of influenza remains an important public health concern. Vaccination is considered the best method of protecting against influenza and its attendant complications. However, the efficacy of any influenza vaccine will depend on how closely the vaccine strains match the circulating wild strains. Historical data show that when the vaccine and circulating strains are similar, influenza vaccines are 70-90% effective in preventing influenza-like illness in healthy adults aged <65 years, but only 30-40% effective in those aged >65 years.
The variable nature of influenza viruses and the constant change in the dominant wild strains usually require that the composition of influenza vaccines be altered annually. Recommendations for which antigens to include in each year's vaccine formulation are made by the World Health Organization (WHO) in co-operation with regulatory authorities, based on international surveillance data. To comply with regulatory requirements of the European Agency for the Evaluation of Medicinal Products (EMEA), clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine meet the criteria set by the Committee for Proprietary Medicinal Products (CPMP) of the EMEA.
GlaxoSmithKline Biologicals' trivalent inactivated split-influenza vaccine has been licensed as Influsplit SSW in Germany since July 1991 and has been available elsewhere as Fluarix or
-Rix since 1992. Fluarix is currently licensed in 76 countries worldwide. The vaccine is well tolerated and has consistently exceeded the EMEA criteria for immunogenicity required for annual registration. We report the results of studies in healthy adult volunteers that were performed between 1992 and 2001 to demonstrate safety and immunogenicity of the vaccine to the regulatory authorities in Europe. We also report the results of similar studies in children and in those considered at high risk of developing influenza-related complications.
Use of tradenames is for product identification only and does not imply endorsement.
Background: The trivalent inactivated split-influenza vaccine, Fluarix has been available since 1992.
Aim: To assess the safety and immunogenicity of the vaccine from studies in healthy adults and the elderly performed from 1992 to 2001 to comply with European Union registration requirements, and from studies in children and populations at high risk of severe influenza illness or influenza-related complications.
Methods: Annual registration studies were performed in healthy adults aged 18-60 years and the elderly aged >60 years. Six studies in children aged 6 months years, and five studies in adults with high-risk conditions, were done during the same period. The high-risk populations included immunosuppressed patients with solid tumours or systemic malignancies, renal or liver transplant recipients, and patients with chronic obstructive pulmonary disease or insulin-dependent diabetes mellitus. Adults and children aged >36 months received 0.5ml of the vaccine by intramuscular or deep subcutaneous injection. Children aged 6-35 months received 0.25ml; in some children not previously vaccinated or exposed to influenza, a second dose was given 4 weeks later. Immunogenicity was determined by measuring haemagglutination inhibiting antibodies just before and 21 ± 2 days after vaccination. Redness, swelling, induration and pain at the injection site were recorded, along with systemic symptoms such as fever.
Results: In all registration studies (n = 1 558), the vaccine consistently exceeded European Union immunogenicity criteria. Geometric mean titres in adults peaked 21 days after vaccination and remained above the protection level for all three strains for up to 12 months. In healthy adults and the elderly, seroprotection rates were 69-100% and consistently exceeded 82% from 1996. Immunogenicity in children (n = 364) and high-risk populations (n = 285) exceeded the targets for healthy adults. The vaccine was well tolerated in all age groups and populations. The most frequently reported symptoms in healthy adults and the elderly were local redness of >20mm (10-31%) and swelling of >20mm (11-16%). The incidence of fever >38.5°C was in healthy adults and high-risk groups; fever of >37°C was also rare (0-5%) in children over 6 years old, but was more frequent in younger children (11-27%). The reactogenicity of the vaccine was low in the high-risk populations.
Conclusions: Fluarix has a good safety profile and is highly immunogenic in all age groups as well as in high-risk populations. The all-year persistence of antibodies means that the vaccine gives protection for the entire influenza season.
Influenza is a highly contagious febrile illness caused by infection of the respiratory tract by influenza viruses A and B. The infection is transmitted via respiratory secretions expelled during sneezing or coughing. Influenza epidemics usually occur every year, almost exclusively during the winter months in temperate climates: October to April in the northern hemisphere and May to September in the southern hemisphere. However, influenza activity occurs throughout the year in tropical regions. In a typical epidemic, 5-15% of the general population can become infected. Annual epidemics occur because the virus can mutate quickly, often producing new strains with minor changes in their surface antigenic glycoproteins (antigenic drift), against which humans have incomplete immunity. Both influenza A and influenza B can cause epidemics.
Occasionally viruses undergo major antigenic changes (antigenic shift) and these can cause influenza epidemics worldwide - pandemics. In the past, pandemics have been caused by influenza A viruses only. The lack of immunity against the 'new' virus makes large sections of the population particularly susceptible to severe disease and increased mortality. The great 'Spanish flu' pandemic in 1918-1920 killed 20-50 million people worldwide, mainly those aged 20-40 years.
Those that become infected with the virus may be asymptomatic, but at worst the infection may lead to a severe respiratory tract illness, with systemic symptoms affecting a wide range of organs, and eventually death. In most people with no chronic illness, symptoms include fever, unproductive cough, sore throat, runny or stuffy nose, headache, muscle aches, loss of appetite and often extreme fatigue. Most people usually recover within 1-2 weeks from the onset of symptoms.
Compared with the effect it has on healthy adults, influenza can cause a more serious illness and greater mortality in groups such as the very young or elderly, the immunocompromised, and those with chronic diseases including chronic obstructive pulmonary disease (COPD), asthma, cardiovascular disease and diabetes. These groups are considered to be at high risk, because influenza may exacerbate their underlying disease or predispose them to secondary complications such as pneumonia or bacterial infections. During the 1978-1981 influenza epidemics in Houston, the highest hospitalisation rates due to acute respiratory illness were 197/100 000 for those considered to be at high risk of developing influenza-related complications compared with 93/100 000 for those at 'normal' risk. Estimates of influenza and pneumonia deaths per 100 000 individuals range from 2 for 45-64-year-olds without chronic disease to 797 for those aged over 65 years with two or more high-risk conditions. During influenza epidemics, 80-90% of excess deaths occur among those over 65 years old.
The effective management of influenza remains an important public health concern. Vaccination is considered the best method of protecting against influenza and its attendant complications. However, the efficacy of any influenza vaccine will depend on how closely the vaccine strains match the circulating wild strains. Historical data show that when the vaccine and circulating strains are similar, influenza vaccines are 70-90% effective in preventing influenza-like illness in healthy adults aged <65 years, but only 30-40% effective in those aged >65 years.
The variable nature of influenza viruses and the constant change in the dominant wild strains usually require that the composition of influenza vaccines be altered annually. Recommendations for which antigens to include in each year's vaccine formulation are made by the World Health Organization (WHO) in co-operation with regulatory authorities, based on international surveillance data. To comply with regulatory requirements of the European Agency for the Evaluation of Medicinal Products (EMEA), clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine meet the criteria set by the Committee for Proprietary Medicinal Products (CPMP) of the EMEA.
GlaxoSmithKline Biologicals' trivalent inactivated split-influenza vaccine has been licensed as Influsplit SSW in Germany since July 1991 and has been available elsewhere as Fluarix or
-Rix since 1992. Fluarix is currently licensed in 76 countries worldwide. The vaccine is well tolerated and has consistently exceeded the EMEA criteria for immunogenicity required for annual registration. We report the results of studies in healthy adult volunteers that were performed between 1992 and 2001 to demonstrate safety and immunogenicity of the vaccine to the regulatory authorities in Europe. We also report the results of similar studies in children and in those considered at high risk of developing influenza-related complications.
Use of tradenames is for product identification only and does not imply endorsement.
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