Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trial of another vaccine, and may not reflect the rates observed in practice.

Fluzone – Children 6 Months through 8 Years of Age

In a multi-center study conducted in the US, children 6 months through 35 months of age received two 0.25 mL doses of Fluzone, and children 3 years through 8 years of age received two 0.5 mL doses of Fluzone, irrespective of previous influenza vaccination history. The two doses (year 2006-2007 formulation) were administered 26 to 30 days apart. The safety analysis set included 97 children 6 months through 35 months of age and 163 children 3 years through 8 years of age. Table 4 and Table 5 summarize solicited injection site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards.

Table 4: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 6 Through 35 Months of Age

Table 5: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 3 Through 8 Years of Age

During the period from the first vaccination through 6 months following the second vaccination, there were no serious adverse events considered to be caused by vaccination and no deaths reported in this study.

Fluzone and Fluzone Intradermal – Adults

Adults 18 through 64 years of age were randomized to receive Fluzone Intradermal or Fluzone (year 2008-2009 formulation) in a multi-center trial conducted in the US. The trial was open-label for administration route. The safety analysis set included 2855 Fluzone Intradermal recipients and 1421 Fluzone recipients. Table 6 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. With the exception of pain, solicited injection-site reactions were more frequent after vaccination with Fluzone Intradermal compared to Fluzone. Nine percent of Fluzone recipients and 49% of Fluzone Intradermal recipients had an injection-site reaction present beyond Day 3 post-vaccination.

Approximately 20% of subjects in both groups had a solicited systemic adverse event present beyond Day 3 post-vaccination.

Table 6: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccine Injection, Adults 18 Through 64 Years of Age

Within 28 days post-vaccination, a serious adverse event was reported by 10 (0.4%) Fluzone Intradermal recipients and 5 (0.4%) Fluzone recipients. Within 6 months post-vaccination, a serious adverse event was reported by 47 (1.6%) Fluzone Intradermal recipients and 20 (1.4%) Fluzone recipients. No deaths were reported during the 6 months post-vaccination. Throughout the study, one reported serious adverse event was considered to be caused by vaccination: a pruritic rash on the extremities and torso that began 48 hours after receipt of Fluzone Intradermal and resulted in hospitalization and treatment with an antihistamine and steroids.

Fluzone and Fluzone High-Dose – Geriatric Adults

Adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (year 2006-2007 formulation) in a multi-center, double-blind trial conducted in the US. The safety analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients.

Table 7 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.

Table 7: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccine Injection, Adults 65 Years of Age and Older

Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event. No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during the period Day 29-180 post-vaccination: 16 (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone High-Dose. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strengh of evidence for a causal relationship to Fluzone or Fluzone High-Dose.

Events Reported During Post-Approval Use of Fluzone

• Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
• Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
• Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
• Vascular Disorders: Vasculitis, vasodilatation/flushing
• Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis
• Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
• General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain

Events Reported During Post-Approval Use of Fluzone High-Dose

• Gastrointestinal Disorders: Nausea, vomiting, diarrhea

Read the Fluzone (influenza virus vaccine) Side Effects Center for a complete guide to possible side effects »

Data evaluating the concomitant administration of Fluzone, Fluzone High-Dose, or Fluzone Intradermal with other vaccines are not available.

Last reviewed on RxList: 1/11/2012
This monograph has been modified to include the generic and brand name in many instances.