Prior to the approval and marketing of Fluarix, the vaccine was administered to 1,271 adults in clinical trials. In Study FLUARIX-US-001, a total of 952 healthy adults, 18 to 64 years of age (54% female and 80% Caucasian), were assessed for adverse drug events (ADEs) after the administration of Fluarix or placebo. Solicited ADEs were observed and collected on the day of vaccination and on the three subsequent days (Table 4). Unsolicited events that occurred within 21 days of vaccination were also recorded on diary cards, and medical histories were disclosed by the study subjects.
The unsolicited ADEs associated with Fluarix, compared with placebo, respectively, included upper respiratory tract infection (3.9% vs. 2.6%), nasopharyngitis (2.5% vs. 1.6%), nasal congestion (2.2% vs. 2.1°%), diarrhea (1.6°% vs. 0°%), influenza-like illness (1.6% vs. 0.5%), vomiting (1.4% vs. 0%), and dysmenor-rhea (1.3% vs. 1.0%). The subjects reported that most ADEs were mild and self-limiting.
Certain medications possess the potential for an interaction when influenza vaccination is administered. Although controlled studies have not shown consistent results, influenza vaccination may contribute to the inhibition of the clearance (Bristol-Myer Squibb), (e.g., Theo-Dur, Key), and (Dilantin canadian, Pfizer).
Table 4 Solicited Adverse Events in Study FLUARIX-US-001
|Adverse Drug Event||Placebo (N = 192)*||Fluarix (N = 760)*|
|Pain||12.0 (7.7-17.4)||54.7 (51.1-58.3)|
|Redness||10.4 (б.5-15.б)||17.5 (l4.9-20.4)|
|Swelling||5.7 (2.9-I0.o)||9.3 (7.4-11.6)|
|Muscle aches||12.0 (7.7-17.4)||23.0 (20.l-26.2)|
|Fatigue||17.7 (l2.6-23.9)||l9.7 (l7.0-22.7)|
|Headache||21.4 (l5.8-27.8)||l9.3 (l6.6-22.3)|
|Arthralgia||6.3 (3.3-10.7)||6.4 (4.8-8.4)|
|Shivering||2.6 (0.9-6.0)||3.3 (2.1-4.8)|
|Fever >100.4°F||1.6 (0.3-4.5)||1.7 (0.9-2.9)|
|*Percent of patients with solicited adverse events within four days of vaccination (95% confidence interval).|
In addition, immunosuppressive therapies such as irradiation, antimetabo-lites, alkylating agents, cytotoxic agents, and corticosteroids (in greater than physiologic doses) may reduce the immune response to the influenza vac-cine.
Fluarix is prepared from influenza viruses propagated in embryonated chicken eggs and therefore should not be administered to individuals with any known systemic hypersensitivities to egg proteins (i.e., eggs or egg products) or chicken proteins. People with known hypersensitivities to any component of Fluarix or those who have had a life-threatening reaction to the previous administration of any influenza vaccine should not receive the vaccine.
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Vaccination should be also delayed in persons with active neurological dis-orders.