Fluzone Quadrivalent: Package Insert / Prescribing Info
Package insert / product label
Generic name: influenza vaccine
Dosage form: suspension for intramuscular injection
Drug class: Viral vaccines
Medically reviewed by Drugs.com. Last updated on Jul 29, 2024.
On This Page
- Indications and Usage
- Dosage and Administration
- Dosage Forms and Strengths
- Contraindications
- Warnings and Precautions
- Adverse Reactions/Side Effects
- Use In Specific Populations
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- References
- How Supplied/Storage and Handling
- Storage and Handling
- Patient Counseling Information
Highlights of Prescribing Information
Fluzone Quadrivalent (Influenza Vaccine)
Injectable Suspension, for Intramuscular Use
2024-2025 Formula
Initial U.S. Approval: 2013
Indications and Usage for Fluzone Quadrivalent
Fluzone Quadrivalent Dosage and Administration
- For intramuscular use (2)
Age | Vaccination Status | Dose | Schedule |
---|---|---|---|
"-" Indicates information is not applicable | |||
|
|||
6 months through 35 months | Not previously vaccinated with influenza vaccine or unknown vaccination history | Two doses, either 0.25 mL or 0.5 mL* | Administer at least 4 weeks apart |
Previously vaccinated with influenza vaccine | One or two doses†, either 0.25 mL or 0.5 mL* | If two doses, administer at least 4 weeks apart | |
36 months through 8 years | Not previously vaccinated with influenza vaccine or unknown vaccination history | Two 0.5 mL doses | Administer at least 4 weeks apart |
Previously vaccinated with influenza vaccine | One or two 0.5 mL doses† | If two doses, administer at least 4 weeks apart | |
9 years and older | - | One 0.5 mL dose | - |
Dosage Forms and Strengths
Fluzone is an injectable suspension.
For individuals 6 months through 35 months, a single-dose is 0.25 mL or 0.5 mL.
For individuals 36 months and older, a single-dose is 0.5 mL. (3)
Contraindications
Warnings and Precautions
- If Guillain-Barré syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks. (5.1)
Adverse Reactions/Side Effects
- In children 6 months through 35 months of age, the most common (≥10%) injection-site adverse reactions were pain (57%) or tenderness (47%–54%), erythema (23%–37%), and swelling (13%–22%); the most common solicited systemic adverse reactions were irritability (47%–54%), abnormal crying (33%–41%), malaise (38%), drowsiness (31%–38%), appetite loss (27%–32%), myalgia (27%), vomiting (10%–15%), and fever (11%–14%). (6.1)
- In children 3 years through 8 years of age, the most common (≥10%) injection-site adverse reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). (6.1)
- In adults 18 years and older, the most common (≥10%) injection-site adverse reaction was pain (47%); the most common solicited systemic adverse reactions were myalgia (24%), headache (16%), and malaise (11%). (6.1)
- In adults 65 years of age and older, the most common (≥10%) injection-site adverse reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc., at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Use In Specific Populations
.
- Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults. (8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2024
Full Prescribing Information
1. Indications and Usage for Fluzone Quadrivalent
Fluzone® Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Fluzone Quadrivalent is approved for use in persons 6 months of age and older.
2. Fluzone Quadrivalent Dosage and Administration
For intramuscular use
2.1 Dose and Schedule
The dose and schedule for Fluzone Quadrivalent are presented in Table 1.
Age | Vaccination Status | Dose | Schedule |
---|---|---|---|
"-" Indicates information is not applicable | |||
|
|||
6 months through 35 months | Not previously vaccinated with influenza vaccine or unknown vaccination history | Two doses, either 0.25 mL or 0.5 mL* | Administer at least 4 weeks apart |
Previously vaccinated with influenza vaccine | One or two doses†, either 0.25 mL or 0.5 mL* | If two doses, administer at least 4 weeks apart | |
36 months through 8 years | Not previously vaccinated with influenza vaccine or unknown vaccination history | Two 0.5 mL doses | Administer at least 4 weeks apart |
Previously vaccinated with influenza vaccine | One or two 0.5 mL doses† | If two doses, administer at least 4 weeks apart | |
9 years and older | - | One 0.5 mL dose | - |
2.2 Administration
Fluzone Quadrivalent is clear and slightly opalescent in color. Parenteral drug products should be inspected visually for particulate matter and/or discoloration prior to administration, whenever solution and container permit. If any of these defects or conditions exist, Fluzone Quadrivalent should not be administered.
Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. A maximum of ten doses can be withdrawn from the multi-dose vial.
Administer each dose intramuscularly.
3. Dosage Forms and Strengths
Fluzone Quadrivalent is an injectable suspension. For individuals 6 months through 35 months, a single dose is 0.25 mL or 0.5 mL.
For individuals 36 months and older, a single dose is 0.5 mL.
4. Contraindications
Do not administer Fluzone Quadrivalent to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see Description (11)], including egg protein, or to a previous dose of any influenza vaccine.
5. Warnings and Precautions
5.1 Guillain Barré Syndrome
If Guillain Barré Syndrome (GBS) has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent should be based on careful consideration of the potential benefits and risks.
The 1976 swine influenza vaccine was associated with an elevated risk of 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. (See ref. 1)
5.2 Preventing and Managing Allergic Reactions
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Fluzone Quadrivalent.
5.3 Altered Immunocompetence
If Fluzone Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.
6. Adverse Reactions/Side Effects
In children 6 months through 35 months of age, the most common (≥10%) injection-site adverse reactions were pain (57%) or tenderness (47%– 54%), erythema (23%–37%), and swelling (13%–22%); the most common solicited systemic adverse reactions were irritability (47%– 54%), abnormal crying (33%–41%), malaise (38%), drowsiness (31%– 38%), appetite loss (27%–32%), myalgia (27%), vomiting (10%–15%), and fever (11%–14%).
In children 3 years through 8 years of age, the most common (≥10%) injection-site adverse 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 adverse 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 adverse reaction was pain (33%); the most common solicited systemic adverse reactions were myalgia (18%), headache (13%), and malaise (11%).
6.1 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(s) of another vaccine and may not reflect the rates observed in practice.
Children 6 Months Through 8 Years of Age
Study 1 (NCT01240746) was a single-blind, randomized, active-controlled 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.
Fluzone Quadrivalent‡, §
(N¶=1223) | TIV-1§, #
(B Victoria) (N¶=310) | TIV-2§, Þ
(B Yamagata) (N¶=308) |
|||||||
---|---|---|---|---|---|---|---|---|---|
Any (%) | Grade 2ß
(%) | Grade 3à
(%) | Any (%) | Grade 2ß
(%) | Grade 3à
(%) | Any (%) | Grade 2ß
(%) | Grade 3à
(%) |
|
|
|||||||||
Injection-site adverse reactions | |||||||||
Painè | 57.0 | 10.2 | 1.0 | 52.3 | 11.5 | 0.8 | 50.3 | 5.4 | 2.7 |
Tendernessð | 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)ø | 14.3 | 5.5 | 2.1 | 16.0 | 6.6 | 1.7 | 13.0 | 4.1 | 2.0 |
Malaiseè | 38.1 | 14.5 | 4.6 | 35.2 | 14.8 | 4.7 | 32.4 | 12.8 | 6.8 |
Myalgiaè | 26.7 | 6.6 | 1.9 | 26.6 | 9.4 | 1.6 | 25.0 | 6.8 | 2.7 |
Headacheè | 8.9 | 2.5 | 0.6 | 9.4 | 3.9 | 0.0 | 12.2 | 4.7 | 0.0 |
Irritabilityð | 54.0 | 26.4 | 3.2 | 52.8 | 20.1 | 3.1 | 53.5 | 22.9 | 2.8 |
Crying abnormalð | 41.2 | 12.3 | 3.3 | 36.5 | 8.2 | 1.9 | 29.9 | 10.4 | 2.1 |
Drowsinessð | 37.7 | 8.4 | 1.3 | 32.1 | 3.8 | 0.6 | 31.9 | 5.6 | 0.7 |
Appetite lossð | 32.3 | 9.1 | 1.8 | 33.3 | 5.7 | 1.9 | 25.0 | 8.3 | 0.7 |
Vomitingð | 14.8 | 6.2 | 1.0 | 11.3 | 4.4 | 0.6 | 13.9 | 6.3 | 0.0 |
Fluzone Quadrivalent‡
(N§=1669) | TIV-1¶
(B Victoria) (N§=424) | TIV-2#
(B Yamagata) (N§=413) |
|||||||
---|---|---|---|---|---|---|---|---|---|
Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) | Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) | Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) |
|
|
|||||||||
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)à | 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 |
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. 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.
0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age
Study 2 (NCT02915302) was a randomized, observer-blinded, 2-arm, multi-center safety and immunogenicity study conducted in the US. In this study, 1950 children 6 months through 35 months of age were randomly assigned to receive Fluzone Quadrivalent administered in either a volume of 0.25 mL (Group 1) or 0.5 mL (Group 2). For participants recommended to receive two doses of influenza vaccine as per Advisory Committee on Immunization Practices guidance, the same dose was administered 4 weeks after the first. The safety analysis set included 1941 participants who received at least 1 dose of study vaccine. Of these participants, 49.7% were female, 74.3% were Caucasian, 19.2% were Black, 6.5% were of other racial groups, and 22.0% were Hispanic/Latino.
Table 4 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards for the 0.25 mL and 0.5 mL volumes of Fluzone Quadrivalent in children 6 months through 35 months of age.
Fluzone Quadrivalent 0.25 mL‡ (N§=949) | Fluzone Quadrivalent 0.5 mL‡ (N§=992) |
|||
---|---|---|---|---|
Any (%) | Grade 3¶
(%) | Any (%) | Grade 3¶
(%) |
|
|
||||
Injection-site adverse reactions | ||||
Tenderness | 47.3 | 1.7 | 50.4 | 1.2 |
Redness | 23.1 | 0.0 | 24.3 | 0.2 |
Swelling | 12.9 | 0.1 | 14.7 | 0.0 |
Systemic adverse reactions | ||||
Irritability | 47.4 | 3.6 | 48.6 | 4.0 |
Abnormal Crying | 33.3 | 3.1 | 34.1 | 2.6 |
Drowsiness | 31.9 | 2.1 | 31.3 | 1.6 |
Loss of Appetite | 27.3 | 1.4 | 28.3 | 2.2 |
Fever (≥100.4°F)# | 11.3 | 0.6 | 12.2 | 1.2 |
Vomiting | 10.0 | 0.4 | 10.2 | 0.5 |
The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%), meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the difference in fever rates <5%). Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. Unsolicited non-serious adverse events were reported in 417 (44%) participants in Group 1 and 394 (40%) participants in Group 2. The most commonly reported unsolicited non-serious adverse events in both groups were cough and rhinorrhea. Ten SAEs were reported during the 28-day follow-up period: 5 (0.5%) in Group 1 and 5 (0.5%) in Group 2.
Adults
In Study 3 (NCT00988143), 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 5 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.
Fluzone Quadrivalent‡
(N§=190) | TIV-1¶
(B Victoria) (N§=190) | TIV-2#
(B Yamagata) (N§=190) |
|||||||
---|---|---|---|---|---|---|---|---|---|
Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) | Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) | Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) |
|
|
|||||||||
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)à | 0.0 | 0.0 | 0.0 | 0.5 | 0.5 | 0.0 | 0.5 | 0.5 | 0.0 |
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.
Geriatric Adults
In Study 4 (NCT01218646), 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 6 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.
Fluzone Quadrivalent‡
(N§=225) | TIV-1¶
(B Victoria) (N§=225) | TIV-2#
(B Yamagata) (N§=225) |
|||||||
---|---|---|---|---|---|---|---|---|---|
Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) | Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) | Any (%) | Grade 2Þ
(%) | Grade 3ß
(%) |
|
|
|||||||||
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)à | 1.3 | 0.0 | 0.4 | 0.0 | 0.0 | 0.0 | 0.9 | 0.4 | 0.4 |
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.
6.2 Post-Marketing Experience
The following events have been spontaneously reported during the post-approval use of Fluzone or Fluzone Quadrivalent. 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 or Fluzone Quadrivalent.
- Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
- Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
- Eye Disorders: Ocular hyperemia
- 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, cough, wheezing, throat tightness, oropharyngeal pain, rhinorrhea
- Skin and Subcutaneous Tissue Disorders: Rash, pruritus, and Stevens-Johnson syndrome
- General Disorders and Administration Site Conditions: Asthenia/fatigue, pain in extremities, chest pain
- Gastrointestinal Disorders: Vomiting
8. Use In Specific Populations
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to with Fluzone Quadrivalent. Healthcare providers are encouraged to enroll women who receive Fluzone Quadrivalent during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463.
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data with Fluzone Quadrivalent use in pregnant women are insufficient to inform vaccine-associated risk of adverse developmental outcomes.
A developmental and reproductive toxicity study was performed in female rabbits administered Fluzone Quadrivalent prior to mating and during gestation. The dose was 0.5 mL on each of five occasions (a single human dose is 0.5 mL). This study revealed no adverse effects to the fetus or pre-weaning development and no evidence of impaired female fertility due to Fluzone Quadrivalent (see Data).
Data
Animal Data: A developmental toxicity study was performed in female rabbits administered a Fluzone Quadrivalent by intramuscular injection on 24 and 10 days before insemination, and on Days 6, 12, and 27 of gestation. The dose was 0.5 mL on each occasion (a single human dose is 0.5 mL). This study revealed no vaccine related fetal malformations and no adverse effects on pre-weaning development or female fertility.
Clinical Considerations
Disease-associated Maternal and/or Embryo/Fetal Risk
Pregnant women are at increased risk of complications associated with influenza infection compared to non-pregnant women. Pregnant women who contract influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.
8.2 Lactation
Risk Summary
It is not known whether Fluzone Quadrivalent is excreted in human milk. Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Fluzone Quadrivalent and any potential adverse effects on the breastfed child from Fluzone Quadrivalent or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine.
8.4 Pediatric Use
Safety and effectiveness of Fluzone Quadrivalent in children below the age of 6 months have not been established. Safety and effectiveness of Fluzone Quadrivalent in children 9 through 17 years of age is based on safety and effectiveness in children 6 months through 8 years of age and adults 18 years of age and older.
8.5 Geriatric Use
Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. [See Clinical Studies (14.6).] Antibody responses to Fluzone Quadrivalent are lower in persons ≥65 years of age than in younger adults.
11. Fluzone Quadrivalent Description
Fluzone Quadrivalent (Influenza Vaccine) for intramuscular use 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 containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone Quadrivalent process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration. Antigens from the four strains included in the vaccine are produced separately and then combined to make the quadrivalent formulation.
Fluzone Quadrivalent is an injectable suspension and is clear and slightly opalescent in color.
Antibiotics are not used in the manufacture of Fluzone Quadrivalent.
The Fluzone Quadrivalent prefilled syringe and multi-dose vial presentations are not made with natural rubber latex.
Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2024-2025 influenza season: A/Victoria/4897/2022 IVR-238 (H1N1), A/California/122/2022 SAN-022 (an A/Thailand/8/2022-like virus) (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage).
The amounts of HA and other ingredients per dose of vaccine are listed in Table 7. The single-dose, pre-filled syringe (0.5 mL) 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.
Ingredient | Quantity (per dose) | |
---|---|---|
Fluzone Quadrivalent 0.25 mL Dose | Fluzone Quadrivalent 0.5 mL Dose |
|
"-" Indicates information is not applicable | ||
Active Substance: Split influenza virus, inactivated strains*: | 30 mcg HA total | 60 mcg HA total |
A (H1N1) | 7.5 mcg HA | 15 mcg HA |
A (H3N2) | 7.5 mcg HA | 15 mcg HA |
B/(Victoria lineage) | 7.5 mcg HA | 15 mcg HA |
B/(Yamagata lineage) | 7.5 mcg HA | 15 mcg HA |
Other: | ||
Sodium phosphate-buffered isotonic sodium chloride solution | QS† to appropriate volume | QS† to appropriate volume |
Formaldehyde | ≤50 mcg | ≤100 mcg |
Octylphenol ethoxylate | ≤125 mcg | ≤250 mcg |
Preservative | ||
Single-dose presentation | - | - |
Multi-dose presentation (thimerosal) | 12.5 mcg mercury | 25 mcg mercury |
12. Fluzone Quadrivalent - Clinical Pharmacology
12.1 Mechanism of Action
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.
14. Clinical Studies
The effectiveness of Fluzone Quadrivalent was demonstrated based on clinical endpoint efficacy data for Fluzone (trivalent influenza vaccine) and on an evaluation of serum HI antibody responses to Fluzone Quadrivalent. Fluzone Quadrivalent, an inactivated influenza vaccine that contains the hemagglutinins of two influenza A subtype viruses and two influenza type B viruses, is manufactured according to the same process as Fluzone.
14.1 Efficacy of Fluzone (Trivalent Influenza Vaccine) in Children 6 through 24 Months of Age
Study 5 (NCT not available), 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 0.25 mL 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 8.
Fluzone† | Placebo‡ | Fluzone vs. Placebo | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Year | n§ | N¶ | Rate (n/N)# | (95% CI) | n§ | N¶ | Rate (n/N)# | (95% CI) | Relative Risk (95% CI) | Percent Relative ReductionÞ
(95% CI) |
|
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Year 1ß
(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 2à
(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) |
14.2 Efficacy of Fluzone (Trivalent Influenza Vaccine) in Adults
Study 6 (NCT00538512), 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 9.
Laboratory-Confirmed Symptomatic Influenza | Fluzone‡
(N=813)§ | Placebo¶
(N=325)§ | Fluzone vs. Placebo | |||||
---|---|---|---|---|---|---|---|---|
n# | Rate (%)Þ | (95% CI) | n# | Rate (%)Þ | (95% CI) | Relative Risk (95% CI) | Percent Relative Reductionß
(95% CI) |
|
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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) |
14.3 Immunogenicity of Fluzone Quadrivalent in Children 6 Months through 8 Years of Age
In Study 1 (NCT01240746) [see Adverse Reactions (6.1)], 1419 children 6 months through 35 months of age and 2101 children 3 years through 8 years of age were included in the per-protocol immunogenicity analysis. Participants 6 months through 35 months of age received one or two 0.25 mL doses and participants 3 years through 8 years of age received one or two 0.5 mL doses of Fluzone Quadrivalent, TIV-1, or TIV-2. For participants who received two doses, the doses were administered approximately 4 weeks apart. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].
HI antibody geometric mean titers (GMTs) and seroconversion rates 28 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria (see Table 10 and Table 11).
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Antigen Strain | Fluzone Quadrivalent§
N¶=2339 | Pooled TIV# N¶=1181 | GMT Ratio (95% CI)Þ |
|
GMT | GMT | |||
A (H1N1) | 1124 | 1096 | 1.03 (0.93; 1.14) | |
A (H3N2) | 822 | 828 | 0.99 (0.91; 1.08) | |
Fluzone Quadrivalent§
N¶=2339 | TIV-1ß
(B Victoria) N¶=582 | TIV-2à
(B Yamagata) N¶=599 | GMT Ratio (95% CI)Þ |
|
GMT | GMT | GMT | ||
B/Brisbane/60/2008 (B Victoria) | 86.1 | 64.3 | (19.5)è | 1.34 (1.20; 1.50) |
B/Florida/04/2006 (B Yamagata) | 61.5 | (16.3)ð | 58.3 | 1.06 (0.94; 1.18) |
|
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Antigen Strain | Fluzone Quadrivalent§
N¶=2339 | Pooled TIV#
N¶=1181 | Difference of Seroconversion Rates (95% CI)Þ |
|
Seroconversionß (%) | ||||
A (H1N1) | 92.4 | 91.4 | 0.9 (-0.9; 3.0) | |
A (H3N2) | 88.0 | 84.2 | 3.8 (1.4; 6.3) | |
Fluzone Quadrivalent§
N¶=2339 | TIV-1à
(B Victoria) N¶=582 | TIV-2è
(B Yamagata) N¶=599 | Difference of Seroconversion Rates (95% CI)Þ |
|
Seroconversionß (%) | ||||
B/Brisbane/60/2008 (B Victoria) | 71.8 | 61.1 | (20.0)ð | 10.7 (6.4; 15.1) |
B/Florida/04/2006 (B Yamagata) | 66.1 | (17.9)ø | 64.0 | 2.0 (-2.2; 6.4) |
Non-inferiority immunogenicity criteria based on HI antibody GMTs and seroconversion rates were also met when age subgroups (6 months to <36 months and 3 years to <9 years) were examined. In addition, HI antibody GMTs and seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV and the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV).
14.4 Immunogenicity of the 0.5 mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age
In Study 2 (NCT02915302) [see Adverse Reactions (6.1)], 1027 children, 6 months through 35 months of age, were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].
In this study, children 6 months through 35 months of age received one or two doses of either 0.25 mL or 0.5 mL of Fluzone Quadrivalent. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre-specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups >0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). GMT ratios (GMT0.5-mL dose divided by GMT0.25-mL dose) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 1.42 (95% CI: 1.16; 1.74), 1.48 (95% CI: 1.21; 1.82), 1.33 (95% CI: 1.09; 1.62), and 1.41 (95% CI: 1.17; 1.70), respectively. Seroconversion rate (SCR) differences (SCR0.5-mL dose minus SCR0.25-mL dose) for the A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage strains were 4.6% (95% CI: -0.4%; 9.6%), 5.1% (95% CI: 0.4%; 9.8%), 1.3% (95% CI: -2.9%; 5.6%), and 2.6% (95% CI: -1.4%; 6.5%).
14.5 Immunogenicity of Fluzone Quadrivalent in Adults ≥18 Years of Age
In Study 3 (NCT00988143) [see Adverse Reactions (6.1)], 565 adults 18 years of age and older who had received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].
HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria (see Table 12).
|
||||
Antigen Strain | Fluzone Quadrivalent‡
N§=190 | Pooled TIV¶
N§=375 | GMT Ratio (95% CI)# |
|
GMT | GMT | |||
A (H1N1) | 161 | 151 | 1.06 (0.87; 1.31) | |
A (H3N2) | 304 | 339 | 0.90 (0.70; 1.15) | |
Fluzone Quadrivalent‡
N§=190 | TIV-1Þ
(B Victoria) N§=187 | TIV-2ß
(B Yamagata) N§=188 | GMT Ratio (95% CI)# |
|
GMT | GMT | GMT | ||
B/Brisbane/60/2008 (B Victoria) | 101 | 114 | (44.0)à | 0.89 (0.70; 1.12) |
B/Florida/04/2006 (B Yamagata) | 155 | (78.1)è | 135 | 1.15 (0.93; 1.42) |
14.6 Immunogenicity of Fluzone Quadrivalent in Geriatric Adults ≥65 Years of Age
In Study 4 (NCT01218646) [see Adverse Reactions (6.1)], 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)].
HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following TIV for all four strains, based on pre-specified criteria (see Table 13).
Seroconversion rates 21 days following Fluzone Quadrivalent were non-inferior to those following TIV for H3N2, B/Brisbane, and B/Florida, but not for H1N1 (see Table 14). The HI antibody GMT following Fluzone Quadrivalent was higher than that following TIV-1 for B/Florida but not higher than that following TIV-2 for B/Brisbane, based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). Seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV, based on pre-specified criteria (the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV).
|
||||
Antigen Strain | Fluzone Quadrivalent‡
N§=220 | Pooled TIV¶
N§=440 | GMT Ratio (95% CI)# |
|
GMT | GMT | |||
A (H1N1) | 231 | 270 | 0.85 (0.67; 1.09) | |
A (H3N2) | 501 | 324 | 1.55 (1.25; 1.92) | |
Fluzone Quadrivalent‡
N§=220 | TIV-1Þ
(B Victoria) N§=219 | TIV-2ß
(B Yamagata) N§=221 | GMT Ratio (95% CI)# |
|
GMT | GMT | GMT | ||
B/Brisbane/60/2008 (B Victoria) | 73.8 | 57.9 | (42.2)à | 1.27 (1.05; 1.55) |
B/Florida/04/2006 (B Yamagata) | 61.1 | (28.5)è | 54.8 | 1.11 (0.90; 1.37) |
|
||||
Antigen Strain | Fluzone Quadrivalent‡
N§=220 | Pooled TIV¶
N§=440 | Difference of Seroconversion Rates (95% CI)# |
|
SeroconversionÞ(%) | ||||
A (H1N1) | 65.91 | 69.77 | -3.86 (-11.50; 3.56) | |
A (H3N2) | 69.09 | 59.32 | 9.77 (1.96; 17.20) | |
Fluzone Quadrivalent‡
N§=220 | TIV-1ß
(B Victoria) N§=219 | TIV-2à
(B Yamagata) N§=221 | Difference of Seroconversion Rates (95% CI)# |
|
SeroconversionÞ(%) | ||||
B/Brisbane/60/2008 (B Victoria) | 28.64 | 18.72 | (8.60)è | 9.91 (1.96; 17.70) |
B/Florida/04/2006 (B Yamagata) | 33.18 | (9.13)ð | 31.22 | 1.96 (-6.73; 10.60) |
15. References
- 1
- Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998;339:1797-802.
- 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 haemagglutination-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972;70:767-777.
16. How is Fluzone Quadrivalent supplied
16.1 How Supplied
Single-dose, prefilled syringe (clear plunger rod), without needle, 0.5 mL (NDC 49281-924-88) (not made with natural rubber latex). Supplied as package of 10 (NDC 49281-924-50).
Multi-dose vial, 5 mL (NDC 49281-539-78) (not made with natural rubber latex). Supplied as package of 1 (NDC 49281-539-15). A maximum of ten doses can be withdrawn from the multi-dose vial.
16.2 Storage and Handling
Store all Fluzone Quadrivalent 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.
17. Patient Counseling Information
See FDA-approved patient labeling (Patient Information). Inform the vaccine recipient or guardian:
- Fluzone Quadrivalent contains killed viruses and cannot cause influenza.
- Fluzone Quadrivalent stimulates the immune system to produce antibodies that help protect against influenza, but does not prevent other respiratory infections.
- Annual influenza vaccination is recommended.
- Report adverse reactions to their healthcare provider and/or to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967.
- 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. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463.
Vaccine Information Statements must be provided to vaccine recipients or their guardians, as required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
Fluzone is a registered trademark of Sanofi Pasteur Inc.
Manufactured by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
This product's labeling may have been updated. For the most recent prescribing information, please visit https://dailymed.nlm.nih.gov/dailymed/.
Patient Information Sheet
Fluzone® Quadrivalent
Influenza Vaccine
Please read this information sheet before getting Fluzone Quadrivalent. 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 Quadrivalent?
Fluzone Quadrivalent is a vaccine that helps protect against influenza illness (flu).
Fluzone Quadrivalent is for people who are 6 months of age and older.
Vaccination with Fluzone Quadrivalent may not protect all people who receive the vaccine.
Who should not get Fluzone Quadrivalent?
You should not get Fluzone Quadrivalent if you:
- ever had a severe allergic reaction to eggs or egg products.
- ever had a severe allergic reaction after getting any influenza vaccine.
- are younger than 6 months of age.
Tell your healthcare provider if you or your child have or have had:
- Guillain-Barré syndrome (severe muscle weakness) after getting an influenza vaccine.
- problems with your immune system as the immune response may be diminished.
How is the Fluzone Quadrivalent given?
Fluzone Quadrivalent is given as an injection into the muscle.
What are the possible side effects of Fluzone Quadrivalent?
The most common side effects of Fluzone Quadrivalent are:
- pain, redness, and swelling where you got the injection
- muscle aches
- tiredness
- headache
- fever
These are not all of the possible side effects of Fluzone Quadrivalent. You can ask your healthcare provider about other side effects.
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. Sanofi Pasteur Inc. is collecting information on pregnancy outcomes and the health of newborns following vaccination with Fluzone Quadrivalent during pregnancy. Women who receive Fluzone Quadrivalent during pregnancy are encouraged to contact Sanofi Pasteur Inc. directly or have their healthcare provider contact Sanofi Pasteur Inc. at 1-800-822-2463.
What are the ingredients in Fluzone Quadrivalent?
Fluzone Quadrivalent contains 4 killed influenza virus strains.
Other ingredients include formaldehyde and octylphenol ethoxylate. The preservative thimerosal is only in the multi-dose vial of Fluzone Quadrivalent.
Manufactured by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA
PRINCIPAL DISPLAY PANEL - 5 mL Vial Label
NDC 49281-539-78
5 mL Multi-Dose Vial
Influenza Vaccine
Fluzone® Quadrivalent
Rx only
2024-2025 Formula
Contains Preservative. DO NOT FREEZE. Store at 2° to 8°C (35° to 46°F).
SHAKE WELL. Contents: One 5 mL multi-dose vial.
0.25 mL or 0.5 mL dose for 6 – 35 months.
0.5 mL dose for 3 years of age and older.
For Intramuscular Use. See package insert for details.
US Govt License #1725
Mfg by: Sanofi Pasteur Inc.
PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton
NDC 49281-539-15
2024-2025
Formula
Influenza Vaccine
Fluzone® Quadrivalent
Rx only
For 6 months of age and older.
For Intramuscular Use.
5 mL multi-dose vial.
0.25 mL or 0.5 mL dose for 6 – 35 months.
0.5 mL dose for 3 years of age and older.
sanofi
FLUZONE QUADRIVALENT NORTHERN HEMISPHERE
influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/darwin/9/2021 san-010 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension |
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FLUZONE QUADRIVALENT NORTHERN HEMISPHERE
influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated), influenza a virus a/california/122/2022 san-022 (h3n2) antigen (formaldehyde inactivated), influenza b virus b/phuket/3073/2013 antigen (formaldehyde inactivated), and influenza b virus b/michigan/01/2021 antigen (formaldehyde inactivated) injection, suspension |
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Labeler - Sanofi Pasteur Inc. (086723285) |
Registrant - Sanofi Pasteur Inc. (086723285) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Sanofi Pasteur Inc. | 086723285 | MANUFACTURE(49281-539, 49281-924) |
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