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Fluzone Quadrivalent 2016-2017 Formula

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

Last reviewed on RxList 02/27/2017

Fluzone Quadrivalent (influenza vaccine) 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. Common side effects of Fluzone Quadrivalent 2016-2017 Formula include:

  • injection-site reactions (pain, tenderness, redness, swelling),
  • irritability and abnormal crying (in infants 6 to 25 months),
  • feeling unwell (malaise),
  • drowsiness,
  • appetite loss,
  • muscle pain,
  • vomiting,
  • headache, and
  • fever.

The dose of Fluzone Quadrivalent for 6 months through 35 months is one or two 0.25 mL doses, administered at least 4 weeks apart. The dose of Fluzone Quadrivalent for 36 months through 8 years is one or two 0.5 mL doses, administered at least 4 weeks apart. The dose of Fluzone Quadrivalent for 9 years and older is one 0.5 mL dose. Fluzone Quadrivalent 2016-2017 Formula 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 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 Quadrivalent during pregnancy. It is unknown if Fluzone Quadrivalent passes into breast milk. Consult your doctor before breastfeeding.

Our Fluzone Quadrivalent (influenza vaccine) 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.

QUESTION

Which illness is known as a viral upper respiratory tract infection? See Answer
Fluzone Quadrivalent 2016-2017 Formula Professional Information

SIDE EFFECTS

In children 6 months through 35 months of age, the most common ( ≥ 10%) injection-site reactions were pain (57%)a or tenderness (54%)b, erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%)b, abnormal crying (41%)b, malaise (38%)a, drowsiness (38%)b, appetite loss (32%)b, myalgia (27%)a, vomiting (15%)b, and fever (14%). In children 3 years through 8 years of age, the most common ( ≥ 10%) injection-site reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). In adults 18 years and older, the most common ( ≥ 10%) injection-site reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), ¬†headache (16%), and malaise (11%). In adults 65 years of age and older, the most common ( ≥ 10%) injection-site reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%).

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.

Children 6 Months Through 8 Years of Age

Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, activecontrolled multi-center safety and immunogenicity study conducted in the US. In this study, children 6 months through 35 months of age received one or two 0.25 mL doses of either Fluzone Quadrivalent or one of two formulations of a comparator trivalent influenza vaccine (TIV-1 or TIV-2), and children 3 years through 8 years of age received one or two 0.5 mL doses of either Fluzone Quadrivalent, TIV-1, or TIV-2. Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). For participants who received two doses, the doses were administered approximately 4 weeks apart. The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. Among participants 6 months through 8 years of age in the three vaccine groups combined, 49.3% were female (Fluzone Quadrivalent, 49.2%; TIV-1, 49.8%; TIV-2, 49.4%), 58.4% Caucasian (Fluzone Quadrivalent, 58.4%; TIV-1, 58.9%; TIV-2, 57.8%), 20.2% Black (Fluzone Quadrivalent, 20.5%; TIV-1, 19.9%; TIV-2, 19.1%), 14.1% Hispanic (Fluzone Quadrivalent, 14.3%; TIV-1, 13.2%; TIV-2, 14.7%), and 7.3% were of other racial/ethnic groups (Fluzone Quadrivalent, 6.8%; TIV-1, 8.0%; TIV-2, 8.5%). Table 2 and Table 3 summarize 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 each dose and serious adverse events (SAEs) during the 6 months following the last dose.

Table 2: Study 1a: Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 7 Days After Vaccination in Children 6 Months Through 35 Months of Age (Safety Analysis Set)b

  Fluzone Quadrivalentc
(Nf=1223)
TIV-1d (B Victoria)
(Nf=310)
TIV-2e (B Yamagata)
(Nf=308)
Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%)
Injection-site adverse reactions
Paini 57.0 10.2 1.0 52.3 11.5 0.8 50.3 5.4 2.7
Tendernessj 54.1 11.3 1.9 48.4 8.2 1.9 49.7 10.3 0.0
Erythema 37.3 1.5 0.2 32.9 1.0 0.0 33.3 1.0 0.0
Swelling 21.6 0.8 0.2 19.7 1.0 0.0 17.3 0.0 0.0
Systemic adverse reactions
Fever ( ≥ 100.4°F)k 14.3 5.5 2.1 16.0 6.6 1.7 13.0 4.1 2.0
Malaisei 38.1 14.5 4.6 35.2 14.8 4.7 32.4 12.8 6.8
Myalgiai 26.7 6.6 1.9 26.6 9.4 1.6 25.0 6.8 2.7
Headachei 8.9 2.5 0.6 9.4 3.9 0.0 12.2 4.7 0.0
Irritabilitvi 54.0 26.4 3.2 52.8 20.1 3.1 53.5 22.9 2.8
Crying abnormalj 41.2 12.3 3.3 36.5 8.2 1.9 29.9 10.4 2.1
Drowsinessj 37.7 8.4 1.3 32.1 3.8 0.6 31.9 5.6 0.7
Appetite lossj 32.3 9.1 1.8 33.3 5.7 1.9 25.0 8.3 0.7
Vomitingj 14.8 6.2 1.0 11.3 4.4 0.6 13.9 6.3 0.0
aNCT01240746
bThe safety analysis set includes all persons who received at least one dose of study vaccine
cFluzone Quadrivalent containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
d2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
eInvestigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage), non-licensed
fN is the number of participants in the safety analysis set
gGrade 2 - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site tenderness: cries and protests when injection-site is touched; Injectionsite erythema, Injection-site swelling: ≥ 2.5 cm to < 5 cm; Fever: > 101.3°F to ≤ 103.1°F (6 months through 23 months); ≥ 101.2°F to ≤ 102.0°F (24 months through 35 months); Malaise, Myalgia, and Headache: some interference with activity; Irritability: requiring increased attention; Crying abnormal: 1 to 3 hours; Drowsiness: not interested in surroundings or did not wake up for a feed/meal; Appetite loss: missed 1 or 2 feeds/meals completely; Vomiting: 2 to 5 episodes per 24 hours
hGrade 3 - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site tenderness: cries when injected limb is moved, or the movement of the injected limb is reduced; Injection-site erythema, Injection-site swelling: ≥ 5 cm; Fever: > 103.1°F (6 months through 23 months); ≥ 102.1°F (24 months through 35 months); Malaise, Myalgia, and Headache: Significant; prevents daily activity; Irritability: inconsolable; Crying abnormal: > 3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite loss: refuses ≥ 3 feeds/ meals or refuses most feeds/meals; Vomiting: ≥ 6 episodes per 24 hours or requiring parenteral hydration
iAssessed in children 24 months through 35 months of age
jAssessed in children 6 months through 23 months of age
kFever measured by any route

Table 3: Study 1a: Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 7 Days After Vaccination in Children 3 Years Through 8 Years of Age (Safety Analysis Set)b

  Fluzone Quadrivalentc
(Nf=1669)
TIV-1d (B Victoria)
(Nf=424)
TIV-2e (B Yamagata)
(Nf=413)
Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%)
Injection-site adverse reactions
Pain 66.6 15.8 2.1 64.6 9.5 2.0 63.8 11.6 2.8
Erythema 34.1 2.9 1.8 36.8 3.4 1.2 35.2 2.5 1.8
Swelling 24.8 2.8 1.4 25.4 1.5 1.2 25.9 2.5 1.8
Systemic adverse reactions
Fever ( ≥ 100.4°F)i 7.0 2.1 2.1 7.1 2.2 1.2 7.6 2.8 0.8
Headache 23.1 6.8 2.2 21.2 5.1 2.7 24.4 7.5 2.0
Malaise 31.9 11.2 5.5 32.8 11.4 5.6 33.4 10.8 5.0
Myalgia 38.6 12.2 3.3 34.1 9.0 2.7 38.4 11.1 2.8
aNCT01240746
bThe safety analysis set includes all persons who received at least one dose of study vaccine
cFluzone Quadrivalent containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/ Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
d2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
eInvestigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage), non-licensed
fN is the number of participants in the safety analysis set
gGrade 2 - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema, Injection-site swelling: ≥ 2.5 cm to < 5 cm; Fever: ≥ 101.2°F to ≤ 102.0°F; Headache, Malaise, and Myalgia: some interference with activity
hGrade 3 - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema, Injection-site swelling: ≥ 5 cm; Fever: ≥ 102.1°F; Headache, Malaise, and Myalgia: Significant; prevents daily activity
iFever measured by any route

Among children 6 months through 8 years of age, unsolicited non-serious adverse events were reported in 1360 (47.0%) recipients in the Fluzone Quadrivalent group, 352 (48.0%) recipients in the TIV-1 group, and 346 (48.0%) recipients in the TIV-2 group. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. During the 28 days following vaccination, a total of 16 (0.6%) recipients in the Fluzone Quadrivalent group, 4 (0.5%) recipients in the TIV-1 group, and 4 (0.6%) recipients in the TIV-2 group, experienced at least one SAE; no deaths occurred. Throughout the study period, a total of 41 (1.4%) recipients in the Fluzone Quadrivalent group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group, experienced at least one SAE. Three SAEs were considered to be possibly related to vaccination: croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient. One death occurred in the TIV-1 group (a drowning 43 days post-vaccination).

Adults

In study 2 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 years of age and older received one dose of either Fluzone Quadrivalent or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The safety analysis set included 570 recipients, half aged 18-60 years and half aged 61 years or older. Among participants in the three vaccine groups combined, 67.2% were female (Fluzone Quadrivalent, 68.4%; TIV-1, 67.9%; TIV-2, 65.3%), 88.4% Caucasian (Fluzone Quadrivalent, 91.1%; TIV-1, 86.8%; TIV-2, 87.4%), 9.6% Black (Fluzone Quadrivalent, 6.8%; TIV-1, 12.1%; TIV-2, 10.0%), 0.4% Hispanic (Fluzone Quadrivalent, 0.0%; TIV-1, 0.5%; TIV-2, 0.5%), and 1.7% were of other racial/ethnic groups (Fluzone Quadrivalent, 2.1%; TIV-1, 0.5%; TIV-2, 2.2%). Table 4 summarizes solicited injection-site and systemic adverse reactions reported within 3 days post-vaccination via diary cards. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination.

Table 4: Study 2a: Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 3 Days After Vaccination in Adults 18 Years of Age and Older (Safety Analysis Set)b

  Fluzone Quadrivalentc
(Nf=190)
TIV-1d (B Victoria)
(Nf=190)
TIV-2e (B Yamagata)
(Nf=190)
Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%)
Injection-site adverse reactions
Pain 47.4 6.8 0.5 52.1 7.9 0.5 43.2 6.3 0.0
Erythema 1.1 0.0 0.0 1.6 0.5 0.0 1.6 0.5 0.0
Swelling 0.5 0.0 0.0 3.2 0.5 0.0 1.1 0.0 0.0
Induration 0.5 0.0 0.0 1.6 0.5 0.0 0.5 0.0 0.0
Ecchymosis 0.5 0.0 0.0 0.5 0.0 0.0 0.5 0.0 0.0
Systemic adverse reactions
Myalgia 23.7 5.8 0.0 25.3 5.8 0.0 16.8 5.8 0.0
Headache 15.8 3.2 0.5 18.4 6.3 0.5 18.0 4.2 0.0
Malaise 10.5 1.6 1.1 14.7 3.2 1.1 12.1 4.7 0.5
Shivering 2.6 0.5 0.0 5.3 1.1 0.0 3.2 0.5 0.0
Fever ( ≥ 100.4°F)i 0.0 0.0 0.0 0.5 0.5 0.0 0.5 0.5 0.0
aNCT00988143
bThe safety analysis set includes all persons who received study vaccine
cFluzone Quadrivalent containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
d2009-2010 Fluzone TIV containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
e2008-2009 Fluzone TIV containing A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2), and B/Florida/04/2006 (Yamagata lineage), licensed
fN is the number of participants in the safety analysis set
gGrade 2 - Injection-site pain: Some interference with activity; Injection-site erythema, Injectionsite swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5.1 to ≤ 10 cm; Fever: ≥ 101.2°F to ≤ 102.0°F; Myalgia, Headache, Malaise, and Shivering: some interference with activity
hGrade 3 - Injection-site pain: Significant; prevents daily activity; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: > 10 cm; Fever: ≥ 102.1°F; Myalgia, Headache, Malaise, and Shivering: Significant; prevents daily activity
iFever measured by any route

Unsolicited non-serious adverse events were reported in 33 (17.4%) recipients in the Fluzone Quadrivalent group, 45 (23.7%) recipients in the TIV-1 group, and 45 (23.7%) recipients in the TIV-2 group. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. In the follow-up period, there were two SAEs, 1 (0.5%) in the Fluzone Quadrivalent group and 1 (0.5%) in the TIV-2 group. No deaths were reported during the trial period.

Geriatric Adults

In Study 3 (NCT01218646, see http://clinicaltrials.gov), a multi-center, randomized, double-blind trial conducted in the US, adults 65 years of age and older received one dose of either Fluzone Quadrivalent, or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV- 2). Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). The safety analysis set included 675 recipients. Among participants in the three vaccine groups combined, 55.7% were female (Fluzone Quadrivalent, 57.3%; TIV-1, 56.0%; TIV-2, 53.8%), 89.5% Caucasian (Fluzone Quadrivalent, 87.6%; TIV-1, 89.8%; TIV-2, 91.1%), 2.2% Black (Fluzone Quadrivalent, 4.0%; TIV-1, 1.8%; TIV-2, 0.9%), 7.4% Hispanic (Fluzone Quadrivalent, 8.4%; TIV-1, 7.6%; TIV-2, 6.2%) and 0.9% were of other racial/ ethnic groups (Fluzone Quadrivalent, 0.0%; TIV-1, 0.9%; TIV-2, 1.8%).

Table 5 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards. Participants were monitored for unsolicited adverse events and SAEs during the 21 days following vaccination.

Table 5: Study 3a: Percentage of Solicited Injection-site and Systemic Adverse Reactions Within 7 Days After Vaccination in Adults 65 Years of Age and Older (Safety Analysis Set)b

  Fluzone Quadrivalentc
(Nf=225)
TIV-1d (B Victoria)
(Nf=225)
TIV-2e (B Yamagata)
(Nf=225)
Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%) Any (%) Grade 2g (%) Grade 3h (%)
Injection-site adverse reactions
Pain 32.6 1.3 0.9 28.6 2.7 0.0 23.1 0.9 0.0
Erythema 2.7 0.9 0.0 1.3 0.0 0.0 1.3 0.4 0.0
Swelling 1.8 0.4 0.0 1.3 0.0 0.0 0.0 0.0 0.0
Systemic adverse reactions
Myalgia 18.3 4.0 0.4 18.3 4.0 0.0 14.2 2.7 0.4
Headache 13.4 1.3 0.4 11.6 1.3 0.0 11.6 1.8 0.4
Malaise 10.7 4.5 0.4 6.3 0.4 0.0 11.6 2.7 0.9
Fever ( ≥ 100.4°F)i 1.3 0.0 0.4 0.0 0.0 0.0 0.9 0.4 0.4
aNCT01218646
bThe safety analysis set includes all persons who received study vaccine
cFluzone Quadrivalent containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria lineage), and B/Florida/04/2006 (Yamagata lineage)
d2010-2011 Fluzone TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed
eInvestigational TIV containing A/California/07/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/04/2006 (Yamagata lineage), non-licensed
fN is the number of participants in the safety analysis set
gGrade 2 - Injection-site pain: some interference with activity; Injection-site erythema and Injection-site swelling: ≥ 5.1 to ≤ 10 cm; Fever: ≥ 101.2°F to ≤ 102.0°F; Myalgia, Headache, and Malaise: some interference with activity
hGrade 3 - Injection-site pain: Significant; prevents daily activity; Injection-site erythema and Injection-site swelling: > 10 cm; Fever: ≥ 102.1°F; Myalgia, Headache, and Malaise: Significant; prevents daily activity
iFever measured by any route

Unsolicited non-serious adverse events were reported in 28 (12.4%) recipients in the Fluzone Quadrivalent group, 22 (9.8%) recipients in the TIV-1 group, and 22 (9.8%) recipients in the TIV- 2 group. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. Three SAEs were reported during the follow-up period, 2 (0.9%) in the TIV-1 group and 1 (0.4%) in the TIV-2 group. No deaths were reported during the trial period.

Post-Marketing Experience

Currently, there are no post-marketing data available for Fluzone Quadrivalent vaccine.

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 Quadrivalent 2016-2017 Formula (Influenza Vaccine)

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© Fluzone Quadrivalent 2016-2017 Formula Patient Information is supplied by Cerner Multum, Inc. and Fluzone 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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