Fluzone Quadrivalent vaccine professional brochure

Influenza…
bring it on
Fluzone Quadrivalent vaccine is an
inactivated quadrivalent influenza virus
vaccine indicated for the prevention of
influenza disease caused by influenza
subtype A and type B viruses contained
in the vaccine. Fluzone Quadrivalent vaccine
is approved for use in persons 6 months
of age and older.
FLUZONE QUADRIVALENT VACCINE
Stand up to influenza with a 4-strain defense that
helps protect patients 6 months of age and older1
Please click here to see
Important Safety Information.
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The B strain
and the impact of its unpredictability
Circulation of B strains and frequency
of mismatched vaccine B lineage2,5-7
60
40
20
a
b
WHO = World Health Organization.
CDC = Centers for Disease Control and Prevention.
Seasons with mismatched B strain
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Yamagata lineage
2011-2012
2010-2011
2009-2010
2008-2009
2007-2008
0
2001-2002
• Varying prevalence of each of the circulating strains
80
2006-2007
– Current trivalent influenza vaccines protect against
2 A strains but only 1 B strain
100
2005-2006
– Since 2001, 2 distinct B lineages have co-circulated
each season—B Victoria and B Yamagata
Prevalence of co-circulating B strains (%)
• Matching of vaccine strains with the circulating strains
2004-2005
– Selections are based on viral surveillance data
collected by the WHOa and the CDCb
Since 2001, trivalent vaccines have left patients
underprotected due to mismatched B-lineage strains
in 6 of the 11 seasons shown below.
2003-2004
• Predicting which strains will predominate during
a season
> 50% of seasons with
mismatched B lineage2,3,5-7
2002-2003
Effectiveness of seasonal influenza
vaccines depends on several factors2-4
Victoria lineage
Please click here to see
Important Safety Information.
Protection against the B strain is critical
Influenza B virus can
be devastating
Broad protection is needed
against both B strains2
• B strains cause epidemics
every 2 to 4 years 3
According to the CDC, between 1999 and 2009d
QUADRIVALENT INFLUENZA
PROTECTION COULD HAVE
POTENTIALLY PREVENTED2:
• Influenza B virus represented up to
44% of circulating strains between
2001-2002 and 2010-2011 (excludes
the 2009-2010 pandemic) 8
• On average, influenza-associated
hospitalization and mortality rates
are higher with type B influenza than
with type A (H1N1) 3,8
• The impact of circulating B strains is
greater in children and young adults3,8
More than
More than
influenza cases
influenza-related
hospitalizations
2.7 million
On average,
21,000
34%
of influenza-related deaths in
children up to 18 years of age were
due to influenza B8,c
Nearly
c
d
1400 influenza-related deaths
Based on data collected from the 2004-2005 through 2010-2011 seasons. Data from the 2009-2010
pandemic season were not included.8
Based on CDC data from the 1999-2000 through the 2008-2009 seasons.2
Page 3 of 8
Please click here to see
Important Safety Information.
Take on influenza the way you always have,
now with more coverage
Transition to Fluzone Quadrivalent vaccine:
the only difference is the 4-strain protection you help provide
In clinical trials, Fluzone Quadrivalent vaccine induced antibody responses
that were similar to Fluzone vaccine for the strains contained in each.1
Fluzone
Quadrivalent vaccine1
Fluzone
vaccine9
Yes
Yes
Yes
Yes
0.5 mL for patients 3 years of age and older
Yes
Yes
Administration route
Intramuscular
Yes
Yes
Dosing schedule
• 1 or 2 doses for patients 6 months through 8 years of age depending on
vaccination history; if 2 doses, administer ≥4 weeks apart
Yes
Yes
Yes
Yes
Age indication
Presentations
Prefilled syringe
Single-dose vial
Multi-dose vial
Dosing amount
Patients 6 months of age and older
Prefilled syringe and single-dose vial do not contain
preservatives and are not made with natural rubber latex
Multi-dose vial is not made with natural rubber latex;
contains preservative
0.25 mL for patients 6 months through 35 months of age
• 1 dose for patients who are 9 years of age and older
+
H1N1/California/7/2009
H3N2/Texas/50/2012
Inactivated strains10
+
Brisbane/60/2008
Victoria
OnlyNo
contains
B Yamagata lineage
Massachusetts/2/2012
Yamagata
Appropriate reimbursement with unique CPT®e codes: 90685, 90686, 90687, 90688
e
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CPT (Current Procedural Terminology) is a registered trademark of the American Medical Association.
Please click here to see
Important Safety Information.
Take a stand with 4-strain protection 1
for patients 6 months of age and older
Fluzone Quadrivalent vaccine induced antibody responses that
were similar to Fluzone vaccine for the strains contained in each.1
Proven 3-strain immunogenicity
Fluzone
vaccine9
+
H1N1
+
H3N2
Either Victoria
OR Yamagata
Proven 4-strain immunogenicity
Fluzone
Quadrivalent
vaccine1
+
H1N1
+
H3N2
+
Victoria
Yamagata
In multicenter studies with a total of 4745 participants 6 months of age and older in the per-protocol analysis set, Fluzone Quadrivalent vaccine
generated immune responses similar to those following trivalent formulations of Fluzone vaccine for the strains contained in each. Participants
received either Fluzone Quadrivalent vaccine or 1 of 2 comparative trivalent vaccine formulations.1 Each trivalent formulation contained either an
influenza type B virus of the Victoria lineage (B/Brisbane/60/2008) or the Yamagata lineage (B/Florida/4/2006), which corresponded to 1 of the 2
type B viruses in Fluzone Quadrivalent vaccine.1
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Please click here to see
Important Safety Information.
The safety profile for Fluzone Quadrivalent vaccine was 1
comparable to the trivalent formulation of Fluzone vaccine
Most common adverse reactions ≥10% across age groups
Adults
18 years of age and older
Fluzone
Quadrivalent
vaccine
65 years of age and older
Trivalent vaccine 1g Trivalent vaccine 2h
Fluzone
Quadrivalent
vaccine
Trivalent vaccine 1i
Trivalent vaccine 2j
B Victoria
N = 225
B Yamagata
N = 225
B Victoria
N = 190
B Yamagata
N = 190
47.4%
52.1%
43.2%
32.6%
28.6%
23.1%
23.7%
15.8%
10.5%
25.3%
18.4%
14.7%
16.8%
18.0%
12.1%
18.3%
13.4%
10.7%
18.3%
11.6%
6.3%
14.2%
11.6%
11.6%
N = 190
f
N = 225
Solicited Injection-site Reactions
Pain
Solicited Systemic Adverse Reactions
Myalgia
Headache
Malaise
Children
6 through 35 months of age
Fluzone
Quadrivalent
vaccine
3 through 8 years of age
Trivalent vaccine 1i
Trivalent vaccine 2j
B Victoria
N = 310
B Yamagata
N = 308
57.0%
54.1%
37.3%
21.6%
52.3%
48.4%
32.9%
19.7%
50.3%
49.7%
33.3%
17.3%
54.0%
41.2%
38.1%
37.7%
32.3%
26.7%
14.8%
14.3%
8.9%
52.8%
36.5%
35.2%
32.1%
33.3%
26.6%
11.3%
16.0%
9.4%
53.5%
29.9%
32.4%
31.9%
25.0%
25.0%
13.9%
13.0%
12.2%
N = 1223
Fluzone
Quadrivalent
vaccine
Trivalent vaccine 1i
Trivalent vaccine 2j
B Victoria
N = 424
B Yamagata
N = 413
66.6%
NA m
34.1%
24.8%
64.6%
NA
36.8%
25.4%
63.8%
NA
35.2%
25.9%
NA
NA
31.9%
NA
NA
38.6%
NA
7.0%
23.1%
NA
NA
32.8%
NA
NA
34.1%
NA
7.1%
21.2%
NA
NA
33.4%
NA
NA
38.4%
NA
7.6%
24.4%
N = 1669
Solicited Injection-site Reactions
Paink
Tendernessl
Erythema
Swelling
Solicited Systemic Adverse Reactions
Irritabilityl
Abnormal cryingl
Malaisek
Drowsinessl
Appetite lossl
Myalgiak
Vomitingl
Fever
Headachek
f
N = Number of participants in the safety analysis set. g 2009-2010 Fluzone vaccine containing A/Brisbane/59/2007 (H1N1), A Uruguay/716/2007
(H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed. h 2008-2009 Fluzone vaccine containing A/Brisbane/59/2007 (H1N1),
A Uruguay/716/2007 (H3N2), and B/Florida/04/2006 (Yamagata lineage), licensed. i 2010-2011 Fluzone vaccine containing
A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Brisbane/60/2008 (Victoria lineage), licensed.
j
Investigational TIV containing A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), and B/Florida/4/2006
(Yamagata lineage), non-licensed. k Assessed in children 24 months through 35 months of age.l Assessed in
children 6 months through 23 months of age. m NA = Not applicable.
Page 6 of 8
Please click here to see
Important Safety Information.
Sanofi Pasteur has your back with
4-strain protection and years of dedication
Endlessly striving to ensure you and your
patients do not face the influenza season alone
Heritage of commitment
Innovation
40 years of influenza experience and
expertise to help you better manage
the influenza season
Fluzone Quadrivalent vaccine joins the ever-evolving
Fluzone Vaccine Family to help further meet the
immunization needs of each and every patient
Reliability
Support
Consistently delivering vaccines and
helping to manage the volatility of the
influenza season so you can focus on
the care of your patients
From financial savings to educational materials,
we provide tools and resources to help with the
challenges that come with the influenza season
Solutions to back your immunization efforts:
Year-round savings
for vaccine ordering
Online ordering and practice support resources
Bring on new
Fluzone Quadrivalent vaccine.
Bring on the influenza season.
Patient reminder tools via
customizable voice messages
Rely on 4-strain coverage for your patients 6 months of age
and older, from Sanofi Pasteur, your vaccine expert.
Online information about
Fluzone vaccine products
To order Fluzone Quadrivalent vaccine,
log onto VaccineShoppe.com or call
1-800-VACCINE (1-800-822-2463).
Page 7 of 8
Please click here to see
Important Safety Information.
FLUZONE QUADRIVALENT
FLUZONE INTRADERMAL
FLUZONE HIGH-DOSE
VACCINE
VACCINE
VACCINE
FLUZONE PARTNERS PROGRAM
IMPORTANT SAFETY INFORMATION
INDICATION
Fluzone Quadrivalent vaccine is an inactivated quadrivalent influenza virus vaccine indicated for the prevention
of influenza disease caused by influenza subtype A and type B viruses contained in the vaccine. Fluzone
Quadrivalent vaccine is approved for use in persons 6 months of age and older.
SAFETY INFORMATION
The most common local and systemic adverse reactions to Fluzone Quadrivalent vaccine include pain (tenderness
in young children), erythema, and swelling at the injection site; myalgia, malaise, headache, and fever (irritability,
abnormal crying, drowsiness, appetite loss, and vomiting in young children). Other adverse reactions may
occur. Fluzone Quadrivalent vaccine should not be administered to anyone with a known hypersensitivity (eg,
anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multi-dose vial is the only
presentation containing thimerosal), or to a previous dose of any influenza vaccine.
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of previous influenza vaccination, the decision
to give Fluzone Quadrivalent vaccine should be based on careful consideration of the potential benefits and risks.
Vaccination with Fluzone Quadrivalent vaccine may not protect all individuals.
Before administering Fluzone Quadrivalent vaccine, please click here to see full Prescribing Information.
To order Fluzone Quadrivalent vaccine or to learn about the Fluzone Partners Program, please log onto VaccineShoppe.com
or call 1-800-VACCINE (1-800-822-2463). Learn more about Fluzone Quadrivalent vaccine at Fluzone.com.
References: 1. Fluzone Quadrivalent vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2013. 2. Reed C, Meltzer MI, Finelli L, Fiore A.
Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine. 2012;30:1993-1998. 3. Belshe RB. The
need for quadrivalent vaccine against seasonal influenza. Vaccine. 2010;28(suppl):D45-D53. 4. Skowronski DM, De Serres G, Dickinson J, et al. Componentspecific effectiveness of trivalent influenza vaccine as monitored through a sentinel surveillance network in Canada, 2006-2007. J Infect Dis. 2009;199:168179. 5. Centers for Disease Control and Prevention (CDC). Seasonal influenza (flu): 2009-2010 influenza season summary. http://www.cdc.gov/flu/weekly/
weeklyarchives2009-2010/09-10summary.htm. Accessed January 21, 2014. 6. CDC. Seasonal influenza (flu): 2010-2011 influenza season summary. http://
www.cdc.gov/flu/weekly/weeklyarchives2010-2011/10-11summary.htm. Accessed January 21, 2014. 7. Michigan Department of Community Health.
Michigan influenza surveillance summary 2011-2012 influenza season. http://www.michigan.gov/documents/mdch/2011-2012_Influenza_Season_
Summary_394188_7.pdf. Accessed January 21, 2014. 8. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother.
2012;8:81-88. 9. Fluzone vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2013. 10. CDC. FluView: 2012-2013 influenza season week
15 ending April 13, 2013. http://www.cdc.gov/flu/weekly/pdf/External_F1315.pdf. Accessed January 21, 2014.
CPT Codes: 90685, 90686, 90687, 90688
Fluzone and Fluzone Quadrivalent vaccines are manufactured and distributed by Sanofi Pasteur Inc.
SANOFI PASTEUR. Discovery Drive. Swiftwater, Pennsylvania 18370. www.sanofipasteur.us
MKT26390-­1 © 2014 Sanofi Pasteur Inc. 2/14
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