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Fluzone Intradermal Quadrivalent 2016-2017 Formula

Last reviewed on RxList: 10/19/2016
Fluzone Intradermal Quadrivalent 2016-2017 Formula Side Effects Center

Last reviewed on RxList 02/27/2017

Fluzone Intradermal Quadrivalent (Influenza Vaccine) Suspension for Intradermal Injection 2016-2017 Formula is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine, approved for use in persons 18 through 64 years of age. Common side effects of Fluzone Intradermal Quadrivalent include:

  • injection-site reactions, (pain, itching, redness, swelling, and a hard lump),
  • muscle pain,
  • headache,
  • feeling unwell (malaise), and
  • shivering.

The dose of Fluzone Intradermal Quadrivalent is a single 0.1 mL dose for intradermal injection in adults 18 through 64 years of age. Fluzone Intradermal Quadrivalent may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant before receiving Fluzone Intradermal Quadrivalent. The drug manufacturer, Sanofi Pasteur Inc., is maintaining a prospective pregnancy exposure registry to collect data on pregnancy outcomes and newborn health status following vaccination with Fluzone Intradermal Quadrivalent during pregnancy. It is unknown if Fluzone Intradermal Quadrivalent passes into breast milk. Consult your doctor before breastfeeding.

Our Fluzone Intradermal Quadrivalent (Influenza Vaccine) Suspension for Intradermal Injection 2016-2017 Formula Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Fluzone Intradermal Quadrivalent 2016-2017 Formula Professional Information

SIDE EFFECTS

In adults 18 through 64 years of age, the most common ( ≥ 10%) injection-site reactions were pain (53.3%), pruritus (52.1%), erythema (36.7%), swelling (19.5%), and induration (17.0%); the most common solicited systemic adverse reactions were myalgia (34.1%), headache (33.1%), malaise (27.7%), and shivering (12.1%).

Clinical Trials Experience

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

Fluzone Intradermal Quadrivalent In Adults 18 Through 64 Years Of Age

Study 1 (NCT01712984, see http://clinicaltrials.gov) was a randomized, double-blind, active-controlled, multi-center safety and immunogenicity study conducted in the US. In this study, adults 18 through 64 years of age received a single injection of either Fluzone Intradermal Quadrivalent or one of two formulations of a comparator trivalent influenza vaccine by the intradermal route (TIV-ID1 or TIV-ID2). Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Intradermal Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The safety analysis set, comprised of all participants who received a study vaccine, included 3355 recipients. Among participants in the three vaccine groups combined, 61.3% were female, 84.9% White, 11.9% Black, 1.1% Asian, and 2.1% were of other racial/ethnic groups. Table 1 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. Participants were monitored for unsolicited adverse events for 28 days after vaccination and serious adverse events (SAEs) for 6 months after vaccination.

Table 1: Study 1a: Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 7 Days After Vaccination in Adults 18 Through 64 Years of Age (Safety Analysis Set)b

* Fluzone Intradermal Quadrivalent
(Ne=1649-1656)
TIV-ID1 c (B Yamagata)
(Ne=819-820)
TIV-ID2d (B Victoria)
(Ne=836-838)
Any (%) Grade 2f (%) Grade 3g (%) Any (%) Grade 2f (%) Grade 3g (%) Any (%) Grade 2f (%) Grade 3g (%)
Injection-site adverse reactions
Pain 53.3 9.7 1.4 48.2 7.9 1.2 50.1 7.5 1.4
Pruritis 52.1 9.4 2.8 45.4 9.0 1.8 44.6 7.5 2.3
Erythema 36.7 10.9 0.4 34.0 9.8 0.1 32.1 6.3 0.4
Swelling 19.5 4.8 0.1 14.8 3.9 0.0 14.7 2.0 0.0
Induration 17.0 2.8 < 0.1 13.5 1.8 0.0 11.2 2.2 0.0
Ecchymosis 2.6 0.4 0.0 1.8 0.4 0.0 1.8 0.1 0.0
Systemic adverse reactions
Myalgia 34.1 8.1 2.6 29.0 8.2 1.5 31.1 7.4 2.5
Headache 33.1 9.1 3.2 31.3 9.6 2.4 33.2 8.9 1.8
Malaise 27.7 9.2 3.0 26.3 6.6 1.8 30.4 8.4 2.5
Shivering 12.1 2.0 1.4 10.4 2.2 0.6 11.2 3.3 1.6
Fever ( ≥ 100.4°F)h 0.8 0.2 0.2 0.7 0.2 0.1 0.5 0.0 0.0
a NCT01712984
b The safety analysis set includes all persons who received study vaccine
c TIV-ID1: 2012-2013 Fluzone Intradermal TIV containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), and B/Texas/6/2011 (Yamagata lineage), licensed
d TIV-ID2: Investigational Intradermal TIV containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), non-licensed
e N is the number of vaccinated participants with available data for the events listed
f Grade 2 - Injection-site pain and injection-site pruritus: Some interference with activity; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 51 to ≤ 100 mm; Fever: ≥ 101.2°F to ≤ 102.0°F; Myalgia, Headache, Malaise, and Shivering: Some interference with activity
g Grade 3 - Injection-site pain and injection-site pruritus: Significant - prevents daily activity; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: > 100 mm; Fever: ≥ 102.1°F; Myalgia, Headache, Malaise, and Shivering: Significant - prevents daily activity
h Fever measured by any route

Unsolicited non-serious adverse events were reported in 382 (22.8%) recipients in the Fluzone Intradermal Quadrivalent group, 169 (20.2%) recipients in the TIV-ID1 group, and 212 (25.1%) recipients in the TIV-ID2 group. The most commonly reported unsolicited non-serious adverse events were cough, headache, and oropharyngeal pain. During the 28 days following vaccination, a total of 6 (0.4%) recipients in the Fluzone Intradermal Quadrivalent group, 2 (0.2%) recipients in the TIV-ID1 group, and 3 (0.4%) recipients in the TIV-ID2 group experienced at least one SAE; no deaths occurred. Throughout the study period (6 months post-vaccination), a total of 20 (1.2%) recipients in the Fluzone Intradermal Quadrivalent group, 14 (1.7%) recipients in the TIV-ID1 group, and 11 (1.3%) recipients in the TIV-ID2 group experienced at least one SAE. One death (177 days post-vaccination due to acute coronary myocardial infarction) occurred in the Fluzone Intradermal Quadrivalent group. This death was considered not related to the study vaccine by the Investigator.

Fluzone Intradermal (Trivalent Influenza Vaccine) In Adults 18 Through 64 Years Of Age

The safety experience with Fluzone Intradermal (trivalent influenza vaccine) is relevant to Fluzone Intradermal Quadrivalent because both vaccines are manufactured using the same process and have overlapping compositions. In a study of adults 18 through 64 years of age (NCT00772109), safety was evaluated in 2855 Fluzone Intradermal recipients compared to 1421 Fluzone (trivalent influenza vaccine) recipients. Rates of solicited injection-site reactions and systemic adverse events in adults are shown in Table 2.

Table 2: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccine Injection, Adults 18 Through 64 Years of Age

  Fluzone Intradermal
(Na=2798-2802) Percentage
Fluzone
(Na=1392-1394) Percentage
Any Grade 2b Grade 3c Any Grade 2b Grade 3c
Iniection-Site Erythema 76.4 28.8 13.0 13.2 2.1 0.9
Injection-Site Induration 58.4 13.0 3.4 10.0 2.3 0.5
Iniection-Site Swelling 56.8 13.4 5.4 8.4 2.1 0.9
Iniection-Site Pain 51.0 4.4 0.6 53.7 5.8 0.8
Iniection-Site Pruritus 46.9 4.1 1.1 9.3 0.4 0.0
Iniection-Site Ecchymosis 9.3 1.4 0.4 6.2 1.1 0.4
Headache 31.2 6.4 1.5 30.3 6.5 1.6
Myalgia 26.5 4.6 1.5 30.8 5.5 1.4
Malaise 23.3 5.5 2.2 22.2 5.5 1.8
Shivering 7.3 1.5 0.7 6.2 1.1 0.6
Feverd ( ≥ 99.5°F) 3.9 0.6 0.1 2.6 0.4 0.2
a N is the number of vaccinated subjects with available data for the events listed
b Grade 2 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Injection-site pain and Injection-site pruritus: sufficiently discomforting to interfere with normal behavior or activities; Fever: > 100.4°F to ≤ 102.2°F; Headache, Myalgia, Malaise, and Shivering: interferes with daily activities
c Grade 3 - Injection-site erythema, Injection-site induration, Injection-site swelling, and Injection-site ecchymosis: ≥ 5 cm; Injection-site pain: incapacitating, unable to perform usual activities; Injection-site pruritus: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Fever: > 102.2°F; Headache, Myalgia, Malaise, and Shivering: prevents daily activities
d Fever - The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded were 99.9%, < 0.1%, and 0.1%, respectively, for Fluzone Intradermal; and 99.6%, 0.0%, and 0.4%, respectively, for Fluzone

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of the trivalent formulation of Fluzone. 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 strength of evidence for a causal relationship to Fluzone.

Read the entire FDA prescribing information for Fluzone Intradermal Quadrivalent 2016-2017 Formula (Influenza Vaccine)

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© Fluzone Intradermal Quadrivalent 2016-2017 Formula Patient Information is supplied by Cerner Multum, Inc. and Fluzone Intradermal Quadrivalent 2016-2017 Formula Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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