Vaccine Information: FluMist Quadrivalent (Page 4 of 5)

14.2 Immune Response Study of FluMist Quadrivalent in Children and Adolescents

A multi-center, randomized, double-blind, active-controlled, non-inferiority study (MI-CP208) was performed to assess the immunogenicity of FluMist Quadrivalent compared to FluMist (active control) in children and adolescents 2 through 17 years of age. A total of 2312 subjects were randomized by site at a 3:1:1 ratio to receive either FluMist Quadrivalent or one of two formulations of comparator vaccine FluMist, each containing a B strain that corresponded to one of the two B strains in FluMist Quadrivalent (a B strain of the Yamagata lineage or a B strain of the Victoria lineage).

Children 2 through 8 years of age received 2 doses of vaccine approximately 30 days apart; children 9 years of age and older received 1 dose. For children 2 through 8 years of age with a history of influenza vaccination, immunogenicity assessments were performed prior to vaccination and at 28 days after the first dose. For children 2 through 8 years of age without a history of influenza vaccination, immunogenicity assessments were performed prior to vaccination and 28 days after the second dose. For children 9 years of age and older, immunogenicity assessments were performed prior to vaccination and at 28 days post vaccination.

Immunogenicity was evaluated by comparing the 4 strain-specific serum HAI antibody GMTs post dosing and provided evidence that the addition of the second B strain did not result in immune interference to other strains included in the vaccine.

14.3 Effectiveness Study of FluMist in Adults

AV009 was a U.S. multi-center, randomized, double-blind, AF-SPG placebo-controlled trial to evaluate effectiveness of FluMist in adults 18 through 64 years of age without high-risk medical conditions over the 1997-1998 influenza season. Participants were randomized 2:1 (vaccine:placebo). Cultures for influenza virus were not obtained from subjects in the trial, thus efficacy against culture-confirmed influenza was not assessed. The A/Wuhan/359/95 (H3N2) strain, which was contained in FluMist, was antigenically distinct from the predominant circulating strain of influenza virus during the trial period, A/Sydney/05/97 (H3N2). Type A/Wuhan (H3N2) and Type B strains also circulated in the U.S. during the study period. The primary endpoint of the trial was the reduction in the proportion of participants with one or more episodes of any febrile illness, and prospective secondary endpoints were severe febrile illness and febrile upper respiratory illness. Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50 through 64 years of age. Primary and secondary effectiveness endpoints from the age group 18 through 49 years are presented in Table 8. Effectiveness was not demonstrated for the primary endpoint in adults 18 through 49 years of age.

Table 8: Effectiveness of FluMist to Prevent Febrile Illness in Adults 18 through 49 Years of Age During the 7-Week Site-Specific Outbreak Period (Study AV009)

* Number of evaluable subjects (92.7% and 93.0% of FluMist and placebo recipients, respectively). † The predominantly circulating virus during the trial period was A/Sydney/05/97 (H3N2), an antigenic variant not included in the vaccine.
Endpoint	FluMist N = 2411*n (%)	Placebo N = 1226*n (%)	Percent Reduction	(95% CI)
Participants with one or more events of: †Primary Endpoint:Any febrile illnessSecondary Endpoints:Severe febrile illnessFebrile upper respiratory illness	331 (13.73)250 (10.37)213 (8.83)	189 (15.42)158 (12.89)142 (11.58)	10.9 19.5 23.7	(-5.1, 24.4)(3.0, 33.2)(6.7, 37.5)

Effectiveness was shown in a post-hoc analysis using an endpoint of CDC-ILI in the age group 18 through 49 years of age.

14.4 Immune Response Study of FluMist Quadrivalent in Adults

A multi‑center, randomized, double-blind, active-controlled, and non-inferiority study (MI-CP185) was performed to assess the safety and immunogenicity of FluMist Quadrivalent compared to those of FluMist (active control) in adults 18 through 49 years of age. A total of 1800 subjects were randomized by site at a 4:1:1 ratio to receive either 1 dose of FluMist Quadrivalent or 1 dose of one of two formulations of comparator vaccine, FluMist, each containing a B strain that corresponded to one of the two B strains in FluMist Quadrivalent (a B strain of the Yamagata lineage and a B strain of the Victoria lineage).

Immunogenicity in Study MI-CP185 was evaluated by comparing the 4 strain-specific serum HAI antibody GMTs post dosing and provided evidence that the addition of the second B strain did not result in immune interference to other strains included in the vaccine.

14.5 Concomitantly Administered Live Virus Vaccines

In Study AV018, concomitant administration of FluMist, MMR (manufactured by Merck & Co., Inc.) and Varicella Virus Vaccine Live (manufactured by Merck & Co., Inc.) was studied in 1245 subjects 12 through 15 months of age. Subjects were randomized in a 1:1:1 ratio to MMR, Varicella vaccine and AF-SPG placebo (group 1); MMR, Varicella vaccine and FluMist (group 2); or FluMist alone (group 3). Immune responses to MMR and Varicella vaccines were evaluated 6 weeks post-vaccination while the immune responses to FluMist were evaluated 4 weeks after the second dose. No evidence of interference with immune response to measles, mumps, rubella, varicella and FluMist vaccines was observed.

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(25):1797-802.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

FluMist Quadrivalent is supplied in a package of 10 pre-filled, single-dose (0.2 mL) intranasal sprayers. The single-use intranasal sprayer is not made with natural rubber latex.

Carton containing 10 intranasal sprayers: NDC 66019-310-10

Single intranasal sprayer: NDC 66019-310-01

16.2 Storage and Handling

The cold chain [2-8°C (35-46°F)] must be maintained when transporting FluMist Quadrivalent.

FLUMIST QUADRIVALENT SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT. THE PRODUCT MUST NOT BE USED AFTER THE EXPIRATION DATE ON THE SPRAYER LABEL.

DO NOT FREEZE.

Keep FluMist Quadrivalent sprayer in outer carton in order to protect from light.

A single temperature excursion up to 25°C (77°F) for 12 hours has been shown to have no adverse impact on the vaccine. After a temperature excursion, the vaccine should be returned immediately to the recommended storage condition (2°C – 8°C) and used as soon as feasible. Subsequent excursions are not permitted.

Once FluMist Quadrivalent has been administered or has expired, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

17 PATIENT COUNSELING INFORMATION

Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling (Information for Patients and Their Caregivers).

Inform vaccine recipients or their parents/guardians of the need for two doses at least 1 month apart in children 2 through 8 years of age, depending on vaccination history. Provide the Vaccine Information Statements (VIS) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.

17.1 Asthma and Recurrent Wheezing

Ask the vaccinee or their parent/guardian if the vaccinee has asthma. For children younger than 5 years of age, also ask if the vaccinee has recurrent wheezing since this may be an asthma equivalent in this age group. Inform the vaccinee or their parent/guardian that there may be an increased risk of wheezing associated with FluMist Quadrivalent in persons younger than 5 years of age with recurrent wheezing and persons of any age with asthma [see Warnings and Precautions (5.2)].

17.2 Vaccination with a Live Virus Vaccine

Inform vaccine recipients or their parents/guardians that FluMist Quadrivalent is an attenuated live virus vaccine and has the potential for transmission to immunocompromised household contacts.

17.3 Adverse Event Reporting

Instruct the vaccine recipient or their parent/guardian to report adverse reactions to their healthcare provider.

FluMist^® is a registered trademark of MedImmune, LLC.

Manufactured by:
MedImmune, LLC
Gaithersburg, MD 20878
1-877-633-4411
U.S. Government License No. 1799

Issue Date: August 2023

Information for Patients and Their Caregivers

FluMist^® Quadrivalent (pronounced FLEW-mĭst Kwä-drə-VĀ-lənt)
(Influenza Vaccine Live, Intranasal)

Please read this Patient Information carefully before you or your child is vaccinated with FluMist Quadrivalent.

This is a summary of information about FluMist Quadrivalent. It does not take the place of talking with your healthcare provider about influenza vaccination. If you have questions or would like more information, please talk with your healthcare provider.

What is FluMist Quadrivalent?

FluMist Quadrivalent is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FluMist Quadrivalent is similar to MedImmune’s trivalent Influenza Vaccine Live, Intranasal (FluMist), except FluMist Quadrivalent provides protection against an additional influenza strain. FluMist Quadrivalent may not prevent influenza in everyone who gets vaccinated.

Who should not get FluMist Quadrivalent?

You should not get FluMist Quadrivalent if you:

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have a severe allergy to eggs or to any inactive ingredient in the vaccine (see “What are the ingredients in FluMist Quadrivalent?”)

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have ever had a life-threatening reaction to influenza vaccinations

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are 2 through 17 years old and take aspirin or medicines containing aspirin. Children or adolescents should not be given aspirin for 4 weeks after getting FluMist or FluMist Quadrivalent unless your healthcare provider tells you otherwise.

Please talk to your healthcare provider if you are not sure if the items listed above apply to you or your child.

Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent.

Who may not be able to get FluMist Quadrivalent?

Tell your healthcare provider if you or your child:

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are currently wheezing

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have a history of wheezing if under 5 years old

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have had Guillain-Barré syndrome

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have a weakened immune system or live with someone who has a severely weakened immune system

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have problems with your heart, kidneys, or lungs

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have diabetes

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are pregnant or nursing

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are taking Tamiflu^® , Relenza^® , amantadine, or rimantadine

If you or your child cannot take FluMist Quadrivalent, you may still be able to get an influenza shot. Talk to your healthcare provider about this.

How is FluMist Quadrivalent given?

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FluMist Quadrivalent is a liquid that is sprayed into the nose.

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You can breathe normally while getting FluMist Quadrivalent. There is no need to inhale or “sniff” it.

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People 9 years of age and older need one dose of FluMist Quadrivalent each year.

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Children 2 through 8 years old may need 2 doses of FluMist Quadrivalent, depending on their history of previous influenza vaccination. Your healthcare provider will decide if your child needs to come back for a second dose.

What are the possible side effects of FluMist Quadrivalent?

The most common side effects are:

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runny or stuffy nose

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sore throat

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fever over 100°F

Other possible side effects include:

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decreased appetite

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irritability

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tiredness

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cough

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headache

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muscle ache

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chills

Call your healthcare provider or go to the emergency department right away if you or your child experience:

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hives or a bad rash

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trouble breathing

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swelling of the face, tongue, or throat

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

Call your healthcare provider for medical advice about side effects. You may report side effects to VAERS at 1‑800‑822‑7967 or http://vaers.hhs.gov.

What are the ingredients in FluMist Quadrivalent?

Active Ingredient: FluMist Quadrivalent contains 4 influenza virus strains that are weakened (A(H1N1), A(H3N2), B Yamagata lineage, and B Victoria lineage).

Inactive Ingredients: monosodium glutamate, gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin.

FluMist Quadrivalent does not contain preservatives.

How is FluMist Quadrivalent Stored?

FluMist Quadrivalent is stored in a refrigerator (not the freezer) between 35-46°F (2-8°C) upon receipt. FluMist Quadrivalent sprayer must be kept in the carton until use in order to protect from light. FluMist Quadrivalent must not be used after the expiration date on the sprayer label.

If you would like more information, talk to your healthcare provider or visit www.flumistquadrivalent.com or call 1‑877‑633-4411.

FluMist^® is a registered trademark of MedImmune, LLC.

Other brands listed are registered trademarks of their respective owners and are not trademarks of MedImmune, LLC.

Manufactured by:

MedImmune, LLC

Gaithersburg, MD 20878

Issue date: August 2023RAL-FLUQV12