Fluarix consists of the hemagglutinins of three virus strains expected to be circulating during the upcoming winter season. Three strains were included in the 2005-2006 vaccine formulation:

  • A/New York/55/2004 (H3N2) (an A/California/7/2004-like strain)
  • A/New Caledonia/20/99 (H1N1)
    • B/Jiangsu/10/2003 (a B/Shang-hai/361/2002-like strain)

Although the vaccine is formulated without preservatives, thimerosal is used during the early stages of manufacturing. It is removed by subsequent purification techniques (to less than 1.25 mcg of mercury per dose).

Table 2 Hemagglutinin-Inhibition Antibody Titers of 1:40 or Higher in Study FLUARIX-US-001

Placebo (N = 190)* Fluarix (N = 745)*
Influenza Strain (Antigen)

Pre-vaccination

21 Days after Vaccination

Pre-vaccination

21 Days after Vaccination
A/New Caledonia/20/99 (HINI) A/Wyoming/3/2003 (H3N2) B/Jiangsu/10/2003 52.1 (44.8-59.4) 65.3 (58.0-72.0) 48.9 (41.6-56.3)

51.1 (43.7-58.4)

65.3 (58.0-72.0) 5I.I (43.7-58.4)

54.8 (5I.I-58.4) 68.7 (65.3-72.0) 49.5 (45.9-53.2) 96.6 (95.I-97.8) 99.I (98.I-99.6) 98.8 (97.7-99.4)
* Percent of patients with hemagglutinin-inhibition titers of 1:40 or higher (95% confidence interval).

Influenza vaccination typically provides protection from influenza within two weeks of administration. An annual vaccine protects 70% to 90% of healthy adults from contracting illness. It also allows milder cases of illness to develop in those who receive the vaccine, compared with those who do not, and it is about 80% effective in preventing death among the elderly.

CLINICAL TRIALS: IMMUNOGENICITY IN ADULTS

In Study FLUARIX-US-001, a randomized, double-blind, placebo-controlled trial, researchers evaluated the immune responses of 745 healthy adults, 18 to 64 years of age, to each of the antigens contained in Fluarix vaccine. Three influenza strains were contained in the vaccine:

  • A/New Caledonia/20/99 (H1N1)
  • A/Wyoming/3/2003 (H3N2)
  • B/Jiangsu/10/2003)

Serum obtained from each study participant 21 days after vaccination was compared with the sera of 190 subjects who received a placebo vaccine of normal saline solution. The purpose of this study was to determine the hem-agglutinin-inhibition (HI) antibody titers and seroconversion rates at 21 days after the administration of the vaccine. The criteria for these titers were set at 1:40 or higher after vaccination, a figure that has been associated with at least 50% protection against infection.
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Table 3 Seroconversion in Study FLUARIX-US-001

Influenza Strain (Antigen)

Placebo (N = 190)*

21 Days after Vaccination

Fluarix (N = 745)* 21 Days after Vaccination

A/New Caledonia/20/99 (HINI)

0 (0.0-1.9)

59.6 (56.0-663.I)
A/Wyoming/3/2003 (H3N2)

I.I (0.I-3.8)

6I.9 (58.3-65.4)
B/Jiangsu/I0/2003

I.I (0.I-3.8)

77.6 (74.4-80.5)
* Percent of patients with at least a four-fold rise in hemagglutinin-inhibition titers of 1:40 or higher (95% confidence interval).

At 21 days after vaccination, the Fluarix patients exceeded the HI minimum immunogenicity rate of 87.5% for each antigen and the seroconversion minimum immunogenicity rate of 55.4% for each antigen (Tables 2 and 3).
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