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Fluzone

Last reviewed on RxList: 11/3/2015
Drug Description

Fluzone
(Influenza Vaccine) Intramuscular Injection

DESCRIPTION

Fluzone (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton. X-100), producing a “split virus”. The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.

Fluzone suspension for injection is clear and slightly opalescent in color.

Antibiotics are not used in the manufacture of Fluzone.

No presentation of Fluzone is made with natural rubber latex.

Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2015-2016 influenza season: A/California/07/2009 X-179A (H1N1), A/Switzerland/9715293/2013 NIB-88 (H3N2), and B/Phuket/3073/2013 (B Yamagata lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.

Table 6: Fluzone Ingredients

Ingredient Quantity (per dose)
Fluzone 0.25 mL Dose Fluzone 0.5 mL Dose
Active Substance: Split influenza virus, inactivated strainsa: 22.5 mcg HA total 45 mcg HA total
  A (H1N1) 7.5 mcg HA 15 mcg HA
  A (H3N2) 7.5 mcg HA 15 mcg HA
  B 7.5 mcg HA 15 mcg HA
Other:
  Sodium phosphate-buffered isotonic sodium chloride QSb to appropriate QSb to appropriate
  solution volume volume
  Formaldehyde < 50 mcg < 100 mcg
  Octylphenol ethoxylate < 75 mcg < 150 mcg
  Gelatin 0.05% 0.05%
Preservative
  Single-dose presentations - -
  Multi-dose presentation (thimerosal) 12.5 mcg mercury 25 mcg mercury
a per United States Public Health Service (USPHS) requirement
b Quantity Sufficient
“-” Indicates information is not applicable

For Consumers

What are the possible side effects of influenza virus injectable vaccine?

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side...

Indications & Dosage

INDICATIONS

Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Fluzone is approved for use in persons 6 months of age and older.

DOSAGE AND ADMINISTRATION

  • For intramuscular use only

Dose And Schedule

The dose and schedule for Fluzone are presented in Table 1.

Table 1: Dose and Schedule for Fluzone

Age Dose Schedule
6 months through 35 months One or two dosesa, 0.25 mL each If 2 doses, administer at least 1 month apart
36 months through 8 years One or two dosesa, 0.5 mL each If 2 doses, administer at least 1 month apart
9 years and older One dose, 0.5 mL -
a1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines
“-” Indicates information is not applicable

Administration

Inspect Fluzone visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.

Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. Withdraw a single dose of vaccine using a sterile needle and syringe. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.

The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons ≥ 12 months through 35 months of age, or the deltoid muscle in persons ≥ 36 months of age. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

Fluzone should not be combined through reconstitution or mixed with any other vaccine.

HOW SUPPLIED

Dosage Forms And Strengths

Fluzone is a suspension for injection.

Fluzone is supplied in 1 presentation:

1) Multi-dose vial, 5 mL, for persons 6 months of age and older.

Multi-dose vial, 5 mL (NDC 49281-396-78) (not made with natural rubber latex). Supplied as package of one (NDC 49281-396-15). A maximum of ten doses can be withdrawn from the multidose vial.

Storage And Handling

Store all Fluzone presentations refrigerated at 2° to 8 ° C (35 ° to 46 ° F). DO NOT FREEZE. Discard if vaccine has been frozen.

Between uses, return the multi-dose vial to the recommended storage conditions at 2 ° to 8 ° C (35 ° to 46 ° F).

Do not use after the expiration date shown on the label.

Manufactured by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA. Revised: May 2015

Side Effects & Drug Interactions

SIDE EFFECTS

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

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 (20062007 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 2 and Table 3 summarize solicited injection site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards.

Table 2: Frequency of Solicited Injection Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Children 6 Through 35 Months of Age

  Dose 1
(Na=90-92)
Percentage
Dose 2
(Na=86-87)
Percentage
Any Moderateb Severec Any Moderateb Severec
Injection-Site Tenderness 47.3 8.8 0.0 56.3 3.4 1.1
Injection-Site Erythema 29.3 0.0 0.0 32.2 1.1 0.0
Injection-Site Swelling 16.7 0.0 0.0 14.9 0.0 0.0
Injection-Site Induration 14.4 0.0 0.0 16.1 0.0 0.0
Injection-Site Ecchymosis 14.4 1.1 0.0 14.9 2.3 0.0
Feverd ( ≥ 100.4°F) 11.0 4.4 0.0 10.3 3.4 1.1
Vomiting 6.6 1.1 0.0 8.1 5.8 0.0
Crying Abnormal 31.9 11.0 0.0 18.6 7.0 2.3
Drowsiness 26.4 1.1 0.0 26.7 4.7 0.0
Appetite Lost 23.1 8.8 0.0 19.8 5.8 1.2
Irritability 42.9 19.8 1.1 34.9 17.4 4.7
a N is the number of vaccinated participants with available data for the events listed
b Moderate - Injection-site tenderness: cries and protests when injection site is touched; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Fever: > 101.3.F to ≤ 103.1.F; Vomiting: 2 to 5 episodes per 24 hours; Crying abnormal: 1 to 3 hours; Drowsiness: not interested in surroundings or did not wake up for a meal; Appetite lost: missed 1 or 2 feeds completely; Irritability: requiring increased attention
c Severe - Injection-site tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5 cm; Fever: > 103.1.F; Vomiting: ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: ≥ 3 hours; Drowsiness: sleeping most of the time or difficulty to wake up; Appetite lost: refuses > 3 feeds or refuses most feeds; Irritability: inconsolable
d Fever - The percentage of temperature measurements that were taken by rectal, axillary, or oral routes, or not recorded were 69.2%, 17.6%, 13.2%, and 0.0%, respectively, for Dose 1; and 69.0%, 13.8%, 16.1%, and 1.1%, respectively, for Dose 2

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

  Dose 1
(Na=150-151)
Percentage
Dose 2
(Na=144-145)
Percentage
Any Moderateb Severec Any Moderateb Severec
Injection-Site Pain 59.3 8.0 0.0 62.1 9.7 0.7
Injection-Site Erythema 27.8 3.3 0.7 27.6 2.1 0.7
Injection-Site Swelling 19.9 5.3 0.0 14.5 2.8 0.0
Injection-Site Induration 16.6 2.0 0.0 11.7 1.4 0.0
Injection-Site Ecchymosis 12.6 0.7 0.7 15.2 0.7 0.0
Injection-Site Pruritus 7.3 - - 13.2 - -
Feverd ( ≥ 99.5°F) 11.9 2.6 2.0 9.7 1.4 1.4
Headache 16.7 2.0 0.7 11.8 1.4 1.4
Malaise 20.0 2.7 1.3 14.6 4.2 0.7
Myalgia 28.0 5.3 0.0 17.4 4.2 0.0
a N is the number of vaccinated participants with available data for the events listed
b Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injectionsite erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 2.5 cm to < 5 cm; Fever: > 100.4.F to ≤ 102.2.F; Headache, Malaise, and Myalgia: interferes with daily activities
c Severe - Injection-site pain: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism; Injection-site erythema, Injection-site swelling, Injection-site induration, and Injection-site ecchymosis: ≥ 5 cm; Fever: > 102.2.F; Headache, Malaise, and Myalgia: prevents daily activities
d Fever - The percentage of temperature measurements that were taken by oral or axillary routes, or not recorded were 93.4%, 6.6%, and 0.0%, respectively, for Dose 1; and 93.1%, 6.2%, and 0.7%, respectively, for Dose 2
“-” Indicates information was not collected

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.

Adults

Adults 18 through 64 years of age received Fluzone (2008-2009 formulation) in a multi-center trial conducted in the US. The safety analysis set included 1421 Fluzone recipients. Table 4 summarizes 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, Adults 18 Through 64 Years of Age

  (Na=1392-1394)
Percentage
Any Grade 2b Grade 3c
Injection-Site Erythema 13.2 2.1 0.9
Injection-Site Induration 10.0 2.3 0.5
Injection-Site Swelling 8.4 2.1 0.9
Injection-Site Pain 53.7 5.8 0.8
Injection-Site Pruritus 9.3 0.4 0.0
Injection-Site Ecchymosis 6.2 1.1 0.4
Headache 30.3 6.5 1.6
Myalgia 30.8 5.5 1.4
Malaise 22.2 5.5 1.8
Shivering 6.2 1.1 0.6
Feverd ( ≥ 99.5°F) 2.6 0.4 0.2
a N is the number of vaccinated participants 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 ≤ 02.2.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 99.6%, 0.0%, and 0.4%, respectively

Within 28 days and 6 months post-vaccination, a serious adverse event was reported by 5 (0.4%) and 20 (1.4%) Fluzone recipients, respectively. No serious adverse event was considered to be caused by vaccination. No deaths were reported during the 6 months post-vaccination.

Geriatric Adults

Adults 65 years of age and older received Fluzone (2006-2007 formulation) in a multi-center, double-blind trial conducted in the US. The safety analysis set included 1260 Fluzone recipients.

Table 5 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.

Table 5: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone, Adults 65 Years of Age and Older

  Na=1258-1260
Percentage
Any Moderateb Severec
Injection-Site Pain 24.3 1.7 0.2
Injection-Site Erythema 10.8 0.8 0.6
Injection-Site Swelling 5.8 1.3 0.6
Myalgia 18.3 3.2 0.2
Malaise 14.0 3.7 0.6
Headache 14.4 2.5 0.3
Feverd ( ≥ 99.5°F) 2.3 0.2 0.1
a N is the number of vaccinated participants with available data for the events listed
b Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injectionsite erythema and Injection-site swelling: ≥ 2.5 cm to < 5 cm; Fever: > 100.4.F to ≤ 102.2.F; Myalgia, Malaise, and Headache: interferes with daily activities
c Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injectionsite swelling: ≥ 5 cm; Fever: > 102.2.F; Myalgia, Malaise, and Headache: prevents daily activities
d Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 98.6% and 1.4%, respectively

Within 6 months post-vaccination, 93 (7.4%) Fluzone recipients experienced a serious adverse event (N=1260). No deaths were reported within 28 days post-vaccination. A total of 7 deaths were reported during the period Day 29-180 post-vaccination: 7 (0.6%) among Fluzone recipients (N=1260). The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. No deaths were considered to be caused by vaccination.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use 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.

DRUG INTERACTIONS

Data evaluating the concomitant administration of Fluzone with other vaccines are not available.

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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.

Warnings & Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barre Syndrome

The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barre syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.1 If GBS has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone should be based on careful consideration of the potential benefits and risks.

Preventing And Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Altered Immunocompetence

If Fluzone is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

Limitations Of Vaccine Effectiveness

Vaccination with Fluzone may not protect all recipients.

Patient Counseling Information

See FDA-approved patient labeling (PATIENT INFORMATION).

  • Inform the patient or guardian that Fluzone contains killed viruses and cannot cause influenza.
  • Fluzone stimulates the immune system to produce antibodies that help protect against influenza, but does not prevent other respiratory infections.
  • Annual influenza vaccination is recommended.
  • Instruct vaccine recipients and guardians to report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS).

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Fluzone has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether Fluzone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Fluzone is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Fluzone in children below the age of 6 months have not been established. Safety and immunogenicity of Fluzone were evaluated in children 6 months through 8 years of age. [See ADVERSE REACTIONS and Clinical Studies] Efficacy of Fluzone was evaluated in children 6 through 24 months of age. [See Clinical Studies]

Geriatric Use

Safety and immunogenicity of Fluzone were evaluated in adults 65 years of age and older. [See ADVERSE REACTIONS and Clinical Studies] Antibody responses to Fluzone are lower in persons ≥ 65 years of age than in younger adults.

REFERENCES

1 Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barre syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998;339:1797-802.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

A severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see DESCRIPTION], including egg protein, or to a previous dose of any influenza vaccine is a contraindication to administration of Fluzone.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Mechanism Of Action

Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza virus infection. In some human studies, antibody titers ≥ 1:40 have been associated with protection from influenza illness in up to 50% of participants.2,3

Antibodies against one influenza virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Therefore, influenza vaccines are standardized to contain the hemagglutinins of influenza virus strains representing the influenza viruses likely to be circulating in the US during the influenza season.

Annual vaccination with the current vaccine is recommended because immunity during the year after vaccination declines and because circulating strains of influenza virus change from year to year.

Clinical Studies

Efficacy Of Fluzone In Children 6 through 24 Months Of Age

A randomized, double-blind, placebo-controlled study was conducted at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. The intent-to-treat analysis set included a total of 786 children 6 through 24 months of age. Participants received two doses of either Fluzone (N = 525) or a placebo (N = 261). Among all randomized participants in both years, the mean age was 13.8 months; 52.5% were male, 50.8% were Caucasian, 42.0% were Black, and 7.2% were of other racial groups. Cases of influenza were identified through active and passive surveillance for influenza-like illness or acute otitis media and confirmed by culture. Influenza-like illness was defined as fever with signs or symptoms of an upper respiratory infection. Vaccine efficacy against all influenza viral types and subtypes was a secondary endpoint and is presented in Table 7.

Table 7: Estimated Efficacy of Fluzone Against Culture-Confirmed Influenza in Children Aged 6 through 24 Months during the 1999-2000 and 2000-2001 Influenza Seasons - Intentto- Treat Analysis Seta

Year Fluzoneb Placeboc Fluzone vs. Placebo
nd Ne Rate (n/N)f (95% CI) nd Ne Rate (n/N)f (95% CI) Relative Risk (95% CI) Percent Relative Reductiong (95% CI)
Year 1h (1999- 2000) 15 273 5.5 (3.1; 8.9) 22 138 15.9 (10.3; 23.1) 0.34 (0.18; 0.64) 66 (36; 82)
Year 2 i (2000- 2001) 9 252 3.6 (1.6; 6.7) 4 123 3.3 (0.9; 8.1) 1.10 (0.34; 3.50) -10 (-250; 66)
aThe intent-to-treat analysis set includes all enrolled participants who were randomly assigned to receive Fluzone or placebo and vaccinated
bFluzone: 1999-2000 formulation containing A/Beijing/262/95 (H1N1), A/Sydney/15/97 (H3N2), and B/Yamanashi/166/98 (Yamagata lineage) and 2000-2001 formulation containing A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 (Yamagata lineage)
c“Placebo: 0.4% NaCl
dn is the number of participants with culture-confirmed influenza for the given year of study as listed in the first column
eN is the number of participants randomly assigned to receive Fluzone or placebo for the given year of study as listed in the column headers (intent-to-treat analysis set)
fRate (%) = (n/N) * 100
gRelative reduction in vaccine efficacy was defined as (1-relative risk) x 100
hIncludes all culture confirmed influenza cases throughout the study duration for Year 1 (12 months of follow-up)
iIncludes all culture-confirmed influenza cases throughout the study duration for Year 2 (6 months of follow-up)

Efficacy Of Fluzone In Adults

A randomized, double-blind, placebo-controlled study was conducted in a single US center during the 2007-2008 influenza season. Participants received one dose of either Fluzone vaccine (N = 813), an active comparator (N = 814), or placebo (N = 325). The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo. Participants were 18 through 49 years of age (mean age was 23.3 years); 63.3% were female, 83.1% were Caucasian, and 16.9% were of other racial/ethnic groups. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). Vaccine efficacy of Fluzone against all influenza viral types and subtypes is presented in Table 8.

Table 8: Estimated Efficacy of Fluzone Vaccine Against Influenza in Adults Aged 18 through 49 Years during the 2007-2008 Influenza Season - Intent-to-Treat Analysis Seta

Laboratory- Confirmed Symptomatic Influenza Fluzoneb (N=813)d Placeboc (N=325)d Fluzone vs. Placebo
ne Rate (%)f (95% CI) ne Rate (%)f (95% CI) Relative Risk (95% CI) Percent Relative Reductiong (95% CI)
Positive culture 21 2.6 (1.6; 3.9) 31 9.5 (6.6; 13.3) 0.27 (0.16; 0.46) 73 (54; 84)
Positive PCR 28 3.4 (2.3; 4.9) 35 10.8 (7.6; 14.7) 0.32 (0.20; 0.52) 68 (48; 80)
Positive culture, positive PCR, or both 28 3.4 (2.3; 4.9) 35 10.8 (7.6; 14.7) 0.32 (0.20; 0.52) 68 (48; 80)
aThe intent-to-treat analysis set includes all enrolled participants who were randomly assigned to receive Fluzone or placebo and vaccinated
bFluzone: 2007-2008 formulation containing A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004 (Victoria lineage)
cPlacebo: 0.9% NaCl
dN is the number of participants randomly assigned to receive Fluzone or placebo
en is the number of participants satisfying the criteria listed in the first column
fRate (%) = (n/N) * 100
gRelative reduction in vaccine efficacy was defined as (1 - relative risk) x 100

Immunogenicity Of Fluzone In Children 6 Months through 8 Years Of Age

In a multi-center study conducted in the US, 68 children 6 months through 35 months of age given two 0.25 mL doses of Fluzone and 120 children 3 years through 8 years of age given two 0.5 mL doses of Fluzone were included in the per-protocol analysis set. The two doses (20062007 formulation) were administered 26 to 30 days apart. Females accounted for 42.6% of the participants in the 6 months through 35 months age group and 53.3% of the participants in the 3 years through 8 years age group. Most participants in the 6 months through 35 months and 3 years through 8 years age groups, respectively, were Caucasian (70.6% and 79.2%), followed by Hispanic (19.1% and 13.3%), and Black (7.4% and 4.2%).

The percentage of participants who received influenza vaccination during the previous influenza season was 54.4% for the 6 months through 35 months age group and 27.5% for the 3 years through 8 years age group. Table 9 shows seroconversion rates and the percentage of participants with an HI titer ≥ 1:40 pre-vaccination and one month following the second dose of Fluzone.

Table 9: Percentage (%) with Pre and Post-Vaccination HI Titers ≥ 1:40 and Seroconversion Following the Second Vaccine Injection with Fluzonea in Children 6 Months Through 35 Months and 3 Years Through 8 Years of Age

Antigen Age Group Pre-Vaccination Titer ≥ 1:40 % (95% CI) Post-Vaccinationb Titer ≥ 1:40 % (95% CI) Seroconversionc % (95% CI)
N=68 (6 to 35 months); N=120 (3 through 8 years)
A (H1N1) 6 through 35 months 11.8 (5.2; 21.9) 92.6 (83.7; 97.6) 88.2 (78.1; 94.8)
3 through 8 years 40.0 (31.2; 49.3) 99.2 (95.4; 100.0) 78.3 (69.9; 85.3)
A (H3N2) 6 through 35 months 29.4 (19.0; 41.7) 100.0 (94.7; 100.0) 91.2 (81.8; 96.7)
3 through 8 years 80.0 (71.7; 86.7) 100.0 (97.0; 100.0) 61.7 (52.4; 70.4)
B 6 through 35 months 1.5 (0.0; 7.9) 20.6 (11.7; 32.1) 20.6 (11.7; 32.1)
3 through 8 years 3.3 (0.9; 8.3) 58.3 (49.0; 67.3) 53.3 (44.0; 62.5)
a Children received two doses of Fluzone administered 26 to 30 days apart, irrespective of previous influenza vaccination history
b Post-vaccination HI titers drawn at 28 days post-dose
c Seroconversion: Paired samples with pre-vaccination HI titer < 1:10 and post-vaccination (28 days post-dose 2) titer ≥ 1:40 or a minimum 4-fold increase for participants with pre-vaccination titer ≥ 1:10

Immunogenicity Of Fluzone In Adults

Adults 18 through 64 years of age received Fluzone (2008-2009 formulation) in a multi-center trial conducted in the US. For immunogenicity analyses, there were 1287 participants who received Fluzone in the per-protocol analysis set. There were fewer males (35.8%) than females. The mean age was 42.6 years (ranged from 18.2 through 65.0 years). Most participants were Caucasian (80.0%), followed by Hispanic (11.0%), and Black (6.3%). Table 10 shows seroconversion rates at 28 days following vaccination and the percentage of participants with an HI titer ≥ 1:40 prior to vaccination and 28 days following vaccination.

Table 10: Percentage (%) with Pre and Post-Vaccination HI Titers ≥ 1:40 and Seroconversion in Adult Fluzone Recipients 18 Through 64 Years of Age

Antigen Pre-Vaccination Titer ≥ 1:40 % (95% CI)
Nc=1285-1286
Post-Vaccinationa Titer ≥ 1:40 % (95% CI)
Nc=1283-1285
Seroconversionb % (95% CI)
Nc=1283-1285
A (H1N1) 39.1 (36.4; 41.8) 91.7 (90.0; 93.1) 60.5 (57.7; 63.2)
A (H3N2) 33.6 (31.0; 36.2) 91.4 (89.8; 92.9) 74.8 (72.3; 77.1)
B 41.2 (38.5; 44.0) 89.3 (87.4; 90.9) 54.2 (51.4; 56.9)
a Post-vaccination HI titers drawn at 28 days post-dose
b Seroconversion: Paired samples with pre-vaccination HI titer < 1:10 and post-vaccination (28 days post-dose) titer ≥ 1:40 or a minimum 4-fold increase for participants with pre-vaccination titer ≥ 1:10
c N is the number of vaccinated participants with available data for the immunologic endpoint listed

Immunogenicity Of Fluzone In Geriatric Adults

Adults 65 years of age and older received Fluzone (2006-2007 formulation) in a multi-center trial conducted in the US. For immunogenicity analyses, there were 1275 participants who received Fluzone in the immunogenicity analysis set. Females accounted for 54.7% of participants. The mean age was 72.9 years (ranged from 65 through 94 years of age); 36% of participants were 75 years of age or older. Most participants were Caucasian (92.9%), followed by Hispanic (3.7%), and Black (2.7%). Table 11 shows seroconversion rates at 28 days following vaccination and the percentage of participants with an HI titer ≥ 1:40 prior to vaccination and 28 days following vaccination.

Table 11: Percentage (%) with Pre and Post-Vaccination HI Titers ≥ 1:40 and Seroconversion in Adult Fluzone Recipients 65 Years of Age and Older

Antigen Pre-Vaccination HI Titer ≥ 1:40 % (95% CI)
Nc=1267-1268
Post-Vaccinationa Titer ≥ 1:40 % (95% CI)
Nc=1252
Seroconversionb % (95% CI)
Nc=1248-1249
A (H1N1) 45.9 (43.2; 48.7) 76.8 (74.3; 79.1) 23.1 (20.8; 25.6)
A (H3N2) 68.6 (66.0; 71.2) 96.5 (95.3; 97.4) 50.7 (47.9; 53.5)
B 27.3 (24.9; 29.9) 67.6 (64.9; 70.2) 29.9 (27.4; 32.6)
a Post-vaccination HI titers drawn at 28 days post-dose
b Seroconversion: Paired samples with pre-vaccination HI titer < 1:10 and post-vaccination (28 days post-dose) titer ≥ 1:40 or a minimum 4-fold increase for participants with pre-vaccination titer ≥ 1:10
c N is the number of vaccinated participants with available data for the immunologic endpoint listed

REFERENCES

2 Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004;103:133-138.

3 Hobson D, Curry RL, Beare AS, Ward-Gardner A. The role of serum haemagglutinationinhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972;70:767-777.

Medication Guide

PATIENT INFORMATION

Fluzone®
(Influenza Vaccine)

Please read this information sheet before getting Fluzone vaccine. This summary is not intended to take the place of talking with your healthcare provider. If you have questions or would like more information, please talk with your healthcare provider.

What is Fluzone vaccine?

Fluzone is a vaccine that helps protect against influenza illness (flu).

Fluzone vaccine is for people who are 6 months of age and older.

Vaccination with Fluzone vaccine may not protect all people who receive the vaccine.

Who should not get Fluzone vaccine?

You should not get Fluzone vaccine if you:

  • ever had a severe allergic reaction to eggs or egg products.
  • ever had a severe allergic reaction after getting any flu vaccine.
  • are younger than 6 months of age.

Tell your healthcare provider if you or your child have or have had:

How is the Fluzone vaccine given?

Fluzone vaccine is a shot given into the muscle of the arm.

For infants, Fluzone vaccine is a shot given into the muscle of the thigh.

What are the possible side effects of Fluzone vaccine?

The most common side effects of Fluzone vaccine are:

  • pain, redness, swelling, bruising and hardness where you got the shot
  • muscle aches
  • tiredness
  • headache
  • fever

These are not all of the possible side effects of Fluzone vaccine. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals.

Call your healthcare provider for advice about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

What are the ingredients in Fluzone vaccine?

Fluzone vaccine contains 3 killed flu virus strains.

Inactive ingredients include formaldehyde, octylphenol ethoxylate, and gelatin. The preservative thimerosal is only in the multi-dose vial of Fluzone vaccine.

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