IDflu - flu shot

What is IDflu?

IDflu is a vaccine available as a suspension for injection in pre-filled syringes. Contains fractions of influenza viruses that have been inactivated (killed). IDflu contains three different strains (types) of influenza viruses (i.e. A / New Caledonia / 20/99, A / Wisconsin / 67/2005 and B / Malaysia / 2506/2004).

What is IDflu used for?

IDflu is used for vaccination against influenza in adults, particularly those with an increased risk of developing complications of the disease. The vaccine should be used according to official recommendations. Adults up to the age of 59 are given the concentration minor (containing 9 micrograms of each viral strain). People aged 60 and over are given the highest concentration (containing 15 micrograms of each viral strain).
The vaccine can only be obtained with a prescription.

How is IDflu used?

IDflu is administered as an injection into the surface layer of the skin "intradermally" using a special microinjection system. The recommended administration site is the shoulder.

How does IDflu work?

IDflu is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. IDflu contains fragments of three different strains of the flu virus. When a person is vaccinated, the immune system recognizes fragments of the virus as "foreign" and produces antibodies against that virus. If exposed to any of these strains of viruses in the future, the immune system will be able to produce antibodies more quickly. The antibodies will help the body protect itself from the diseases caused from these influenza virus strains.
Each year, the World Health Organization (WHO) provides recommendations on flu strains to be included in vaccines for the next flu season. These viral strains will need to be incorporated into IDflu before the vaccine can be used. IDflu currently contains fragments of the viral strains. expected to cause influenza in the 2006/2007 season, in accordance with WHO recommendations for the Northern Hemisphere and the European Union (EU). The viral strains contained in IDflu will need to be replaced again before the vaccine can be used in subsequent seasons.

How has IDflu been studied?

The effects of IDflu were first tested in experimental models before being studied in humans.
Four studies involving over 8,000 people were carried out to investigate the effectiveness of IDflu as a protection against influenza. In two of the studies, people under the age of 60 were vaccinated with the concentration of 9 micrograms. In the other two studies, people aged 60 years and older were seen vaccinated with the concentration of 15 micrograms.
In all studies, IDflu was compared with another flu vaccine given by injection into a muscle. The studies compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), comparing the levels of antibodies before injection and after three weeks.

What benefit has IDflu shown during the studies?

In all studies, both IDflu and the comparator vaccine showed adequate antibody levels for protection against all three influenza strains. In adults under the age of 60, the 9 microgram concentration ensured a level of protection equal to that of the intramuscular vaccine. In adults aged 60 and over, the 15 microgram concentration ensured a level of protection equal to that of the intramuscular vaccine.

What is the risk associated with IDflu?

The most common side effects seen with IDflu (seen in more than 1 in 10 patients) are headache, myalgia (muscle pain), malaise and local reactions at the vaccination site (redness, swelling, hardening of the skin, pain and itching) . For the full list of side effects reported with IDflu, see the package leaflet.
IDflu must not be used in people who may be hypersensitive to the active substances, any of the substances, eggs, chicken proteins, neomycin (an antibiotic),
formaldehyde (a preservative) or octoxinol 9 (a cleanser). People with a fever or an acute (short-lived) infection cannot receive the vaccine until complete recovery.

Why has IDflu been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that IDflu's benefits are greater than its risks in the prophylaxis of influenza in adults up to the age of 59 and over 60 years of age, particularly in subjects with an increased risk of developing associated complications. The committee recommended the granting of a marketing authorization for IDflu.

More information about IDflu

On 24 February 2009, the European Commission granted Sanofi Pasteur SA a "Marketing Authorization" for IDflu, valid throughout the European Union.
For the complete version of the IDflu EPAR click here.

Last update of this summary: 02-2009.

The information on IDflu - influenza vaccine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.