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Overall, the most common ( ≥ 10 %) solicited adverse reactions occurring in adults 18 to 64 years of age within 7 days of vaccination with FLUCELVAX were pain at the injection site (28%), erythema at the injection site (13%), headache (16%), fatigue (12%), myalgia (11%) and malaise (10%). The most common ( ≥ 10%) solicited adverse reactions occurring in adults 65 years of age and older within 7 days of vaccination were erythema at the injection site (10%), fatigue (11%), headache (10%) and malaise (10%).
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in clinical studies of another vaccine, and may not reflect rates observed in clinical practice.
The safety of FLUCELVAX was evaluated in seven randomized, controlled studies conducted in the US, Europe and New Zealand. The safety population includes 5709 adults 18 through 64 years of age and 572 adults 65 years of age and older.
In all studies, solicited local injection site and systemic adverse reactions were collected from subjects who completed a symptom diary card for 7 days following vaccination.
One of the 7 clinical trials was a randomized, double-blind, placebo-controlled study that evaluated a total of 11376 subjects: FLUCELVAX (N=3813), placebo (N=3894) and another influenza vaccine. The population was 18 through 49 years of age (mean 32.8 years), 55% were female and 84% were Caucasian. The safety data observed for FLUCELVAX and placebo are summarized in Table 1.
Table 1: Solicited Adverse Reactions in the Safety
Population Reported Within 7 Days of Vaccination in Study 1*
|Adults 18 through 49 Years
|Local adverse reactions|
|Injection site pain||30||10|
|Systemic adverse reactions|
|Fever ( ≥ 38° C)||1||< 1|
Study 2 was a randomized, double-blind study comparing FLUCELVAX (N=1330) to a U.S. licensed comparator (N=1324) in adults 18 years of age or older. The mean age was 43.7 years of age for adults 18 to 64 years of age and 71.3 years of age for adults 65 years of age and older; 57% of subjects were female and 100% were Caucasian. The safety data observed are summarized in Table 2.
Table 2: Solicited Adverse Reactions in the Safety
Population Reported Within 7 Days of Vaccination in Study 2*
|Adults 18 through 64 Years||Adults 65 Years of Age and Older|
|Local adverse reactions|
|Injection site pain||20||15||8||4|
|Systemic adverse reactions|
|Fever ( ≥ 38° C)||1||1||<1||1|
Unsolicited adverse events, including serious adverse events (SAEs), were collected for 21 days after vaccination in five studies. In adults 18 through 64 years of age (N=4038), 13% (284 out of 2266) of subjects who received FLUCELVAX and 13% (224 out of 1772) of subjects who received a U.S. licensed comparator vaccine reported at least one unsolicited adverse event within 21 days after vaccination. The most commonly reported unsolicited adverse events after FLUCELVAX vaccination were rhinitis (3%), headache (2%) and oropharyngeal pain (2%). In adults 65 years of age and older (N=2013), 11% (110 out of 997) of subjects who received FLUCELVAX and 9% ( 95 out of 1016) of subjects who received a U.S. licensed comparator vaccine reported at least one unsolicited adverse event within 21 days after vaccination. Within this age group, the most commonly reported unsolicited adverse events after FLUCELVAX vaccination were rhinitis (3%) and cough (2%). In both age groups, all other unsolicited adverse events were reported in 1% or less of subjects.
In the seven controlled studies of FLUCELVAX, the rates of serious adverse events were collected for 21 days in two studies and for 6 to 9 months in five studies. The rates (in all seven controlled studies) of serious adverse events among adults 18 through 64 years of age were 1% (84 out of 6388) in groups that received FLUCELVAX, 1% (55 out of 5745) in groups that received US licensed comparator vaccines and 1% (37 out of 3894) in groups that received placebo. The rates of serious adverse events among adults 65 years of age and older were 4% (36 out of 997) in groups that received FLUCELVAX and 4% (44 out of 1016) in groups that received a US licensed comparator vaccine.
There are no available postmarketing safety data with FLUCELVAX.
Read the Flucelvax (influenza virus vaccine for injection) Side Effects Center for a complete guide to possible side effects
Concomitant use with Other Vaccines
No data are available to assess the concomitant administration of FLUCELVAX with other vaccines.
If FLUCELVAX is to be given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered at different injection sites. Do not mix FLUCELVAX with any other vaccine in the same syringe or vial.
Concurrent use with Immunosuppressive Therapies
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses) may reduce the immune response to FLUCELVAX. [See Altered Immunocompetence]
2. NCT00630331; see http://clinicaltrials.gov/
3. NCT00492063; see http://clinicaltrials.gov/
Last reviewed on RxList: 11/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Flucelvax Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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