Package Insert - Adacel - FDA

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Five years should have elapsed since the recipient's last dose of tetanus toxoid, diphtheria toxoid. 24 and/or ... tetan
Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Adacel safely and effectively. See full prescribing information for Adacel.



Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions. (5.7) ------------------------------ADVERSE REACTIONS------------------- The most common solicited injection site reactions occurring within 0-14 days following vaccination with Adacel were: - For Adolescents 11-17 years of age: pain (77.8%), swelling (20.9%), erythema (20.8%). - For Adults 18-64 years of age: pain (65.7%), swelling (21.0%), erythema (24.7%). (6.1)  The most common solicited systemic reactions occurring within 0-14 days following vaccination with Adacel were: - For Adolescents 11-17 years of age: headache (43.7%), body ache or muscle weakness (30.4%), tiredness (15.1%). - For Adults 18-64 years of age: headache (33.9%), body ache or muscle weakness (21.9%). (6.1)

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed ) Suspension for Intramuscular Injection Initial US Approval: 2005 ----------------------------RECENT MAJOR CHANGES---------------------Warnings and Precautions. (5.2) 09/2017 ----------------------------INDICATIONS AND USAGE---------------------- Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use as a single dose in persons 10 through 64 years of age. (1) ----------------------DOSAGE AND ADMINISTRATION------------------- A single intramuscular injection of 0.5 mL. (2.1) ---------------------DOSAGE FORMS AND STRENGTHS-----------------To report SUSPECTED ADVERSE REACTIONS, contact  Single-dose vials and prefilled syringes containing a 0.5 mL Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery suspension for injection. (3) Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-------------------------------CONTRAINDICATIONS------------------------VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.  Severe allergic reaction (eg, anaphylaxis) to any component of Adacel ------------------------------DRUG INTERACTIONS-------------------or any other diphtheria toxoid, tetanus toxoid and pertussis antigen When Adacel vaccine was administered concomitantly with containing vaccine. (4.1) trivalent inactivated influenza vaccine (TIV) to adults 19-64  Encephalopathy (eg, coma, decreased level of consciousness, years of age, a lower antibody response was observed for prolonged seizures) within 7 days of administration of a previous pertactin antigen as compared to Adacel vaccine administered pertussis antigen-containing vaccine. (4.2) alone. (7.1, 14.3) -----------------------WARNINGS AND PRECAUTIONS------------------- Immunosuppressive therapies may reduce the immune response to  For one presentation of Adacel, the tip caps of the prefilled syringes Adacel. (7.2) may contain natural rubber latex, which may cause allergic reactions in  Do not mix Adacel vaccine with any other vaccine in the same latex sensitive individuals. (5.2, 16) syringe or vial.  If Guillain-Barré syndrome occurred within 6 weeks of receipt of a -----------------------USE IN SPECIFIC POPULATIONS-----------prior vaccine containing tetanus toxoid, the risk for Guillain-Barré  Safety and effectiveness of Adacel vaccine have not been syndrome may be increased following a subsequent dose of Adacel established in pregnant women. (8.1) vaccine. (5.3)  Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at  Progressive or unstable neurologic conditions are reasons to defer 1-800-822-2463 (1-800-VACCINE). (8.1) Adacel vaccination. (5.4)  Persons who experienced an Arthus-type hypersensitivity reaction See 17 PATIENT COUNSELING INFORMATION following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last Revised: [XXX/2017] dose of a tetanus toxoid-containing vaccine. (5.5) ___________________________________________________________________________________________________________________ 8.3 Nursing Mothers FULL PRESCRIBING INFORMATION: CONTENTS* 8.4 Pediatric Use 1 INDICATIONS AND USAGE 8.5 Geriatric Use 2 DOSAGE AND ADMINISTRATION 11 DESCRIPTION 2.1 Preparation for Administration 12 CLINICAL PHARMACOLOGY 2.2 Administration, Dose and Schedule 12.1 Mechanism of Action 2.3 Additional Dosing Information 13 NON-CLINICAL TOXICOLOGY 3 DOSAGE FORMS AND STRENGTHS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 4 CONTRAINDICATIONS 14 CLINICAL STUDIES 4.1 Hypersensitivity 14.1 Immunological Evaluation in Adolescents and Adults, 10 4.2 Encephalopathy Through 64 Years of Age 5 WARNINGS AND PRECAUTIONS 14.2 Concomitant Hepatitis B Vaccine Administration 5.1 Management of Acute Allergic Reactions 14.3 Concomitant Influenza Vaccine Administration 5.2 Latex 15 REFERENCES 5.3 Guillain-Barré Syndrome and Brachial Neuritis 16 HOW SUPPLIED/STORAGE AND HANDLING 5.4 Progressive or Unstable Neurologic Disorders 17 PATIENT COUNSELING INFORMATION 5.5 Arthus-Type Hypersensitivity 5.6 Altered Immunocompetence * Sections or subsections omitted from the full prescribing information 5.7 Syncope are not listed. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 7.1 Concomitant Vaccine Administration 7.2 Immunosuppressive Treatments 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy

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Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

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FULL PRESCRIBING INFORMATION:

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Adacel® is a vaccine indicated for active booster immunization against tetanus, diphtheria and

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pertussis. Adacel vaccine is approved for use as a single dose in individuals 10 through 64 years

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of age.

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2

DOSAGE AND ADMINISTRATION

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2.1

Preparation for Administration

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Just before use, shake the vial or syringe well until a uniform, white, cloudy suspension results.

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Parenteral drug products should be inspected visually for particulate matter and discoloration

INDICATIONS AND USAGE

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prior to administration, whenever solution and container permit. If either of these conditions exist,

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the vaccine should not be administered.

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When withdrawing a dose from a stoppered vial, do not remove either the stopper or the metal

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seal holding it in place. Use a separate sterile needle and syringe for each injection. Using a sterile

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needle and syringe, withdraw the 0.5 mL dose of vaccine from the single-dose vial and administer

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the vaccine to the individual. Changing needles between withdrawing the vaccine from the vial

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and injecting it into a recipient is not necessary unless the needle has been damaged or

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contaminated.

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

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2.2

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Adacel vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle

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of the upper arm.

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Do not administer this product intravenously, subcutaneously or intradermally.

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There are no data to support repeat administration of Adacel vaccine.

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Five years should have elapsed since the recipient’s last dose of tetanus toxoid, diphtheria toxoid

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and/or pertussis containing vaccine and the administration of Adacel vaccine.

Administration, Dose and Schedule

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Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

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2.3

Additional Dosing Information

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Primary series: The safety and effectiveness of Adacel vaccine used as a primary series or to

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complete the primary series, for diphtheria, tetanus, or pertussis has not been demonstrated.

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Wound management: If tetanus prophylaxis is needed for wound management, Adacel may be

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given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular

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Pertussis Vaccine, Adsorbed (Tdap) has been administered.

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3

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Adacel vaccine is a suspension for injection (0.5 mL dose) available in 0.5 mL single-dose vials

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and prefilled syringes. [See DOSAGE AND ADMINISTRATION (2.2) and HOW

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SUPPLIED/STORAGE AND HANDLING (16).]

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4

CONTRAINDICATIONS

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4.1

Hypersensitivity

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A severe allergic reaction (eg, anaphylaxis) after a previous dose of any tetanus toxoid, diphtheria

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toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication

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to administration of Adacel vaccine. [See DESCRIPTION (11).] Because of uncertainty as to

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which component of the vaccine may be responsible, none of the components should be

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administered. Alternatively, such individuals may be referred to an allergist for evaluation if

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further immunizations are to be considered.

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4.2

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Encephalopathy (eg, coma, prolonged seizures, or decreased level of consciousness) within 7 days

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of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is

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a contraindication to administration of any pertussis containing vaccine, including

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Adacel vaccine.

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5

WARNINGS AND PRECAUTIONS

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5.1

Management of Acute Allergic Reactions

DOSAGE FORMS AND STRENGTHS

Encephalopathy

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Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

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Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be

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available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

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5.2

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For one presentation of Adacel, the tip caps of the prefilled syringes may contain natural rubber

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latex, which may cause allergic reactions in latex sensitive individuals. The vial stopper is not

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made with natural rubber latex. [See HOW SUPPLIED/STORAGE AND HANDLING (16).]

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5.3

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A review by the Institute of Medicine found evidence for acceptance of a causal relation between

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tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (1) If Guillain-Barré

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syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the

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risk for Guillain-Barré syndrome may be increased following a dose of Adacel vaccine.

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5.4

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Progressive or unstable neurologic conditions are reasons to defer Adacel. It is not known whether

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administration of Adacel to persons with an unstable or progressive neurologic disorder might

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hasten manifestations of the disorder or affect the prognosis. Administration of Adacel to persons

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with an unstable or progressive neurologic disorder may result in diagnostic confusion between

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manifestations of the underlying illness and possible adverse effects of vaccination.

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5.5

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Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a

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tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed

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since the last dose of a tetanus toxoid containing vaccine.

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5.6

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If Adacel vaccine is administered to immunocompromised persons, including persons receiving

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immunosuppressive therapy, the expected immune response may not be obtained. [See Drug

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Interactions (7.2).]

Latex

Guillain-Barré Syndrome and Brachial Neuritis

Progressive or Unstable Neurologic Disorders

Arthus-Type Hypersensitivity

Altered Immunocompetence

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Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

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5.7

Syncope

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Syncope (fainting) can occur in association with administration of injectable vaccine, including

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Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions.

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6

ADVERSE REACTIONS

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6.1

Clinical Trials Experience

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Because clinical trials are conducted under widely varying conditions, adverse reaction rates

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observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials

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of another vaccine and may not reflect the rates observed in practice. The adverse reaction

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information from clinical trials does, however, provide a basis for identifying the adverse events

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that appear to be related to vaccine use and for approximating rates of those events. As with any

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vaccine, there is the possibility that broad use of Adacel vaccine could reveal adverse reactions

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not observed in clinical trials.

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The safety of Adacel vaccine was evaluated in 5 clinical studies. A total of 7,143 individuals 10

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through 64 years of age inclusive (4,695 adolescents 10 through 17 years of age and, 2,448 adults

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18 through 64 years of age) received a single dose of Adacel vaccine.

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Clinical study Td506 was a randomized, observer-blind, active controlled trial that enrolled

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adolescents 11 through 17 years of age (Adacel vaccine N = 1,184; Td vaccine N = 792) and

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adults 18 through 64 years of age (Adacel vaccine N = 1,752; Td vaccine N = 573). Study

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participants had not received tetanus or diphtheria containing vaccines within the previous 5

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years. Solicited local and systemic reactions and unsolicited adverse events were monitored daily

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for 14 days post-vaccination using a diary card. From days 14-28 post-vaccination, information on

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adverse events necessitating a medical contact, such as a telephone call, visit to an emergency

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room, physician’s office or hospitalization, was obtained via telephone interview or at an interim

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clinic visit. From days 28 to 6 months post-vaccination, participants were monitored for

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unexpected visits to a physician’s office or to an emergency room, onset of serious illness and

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hospitalizations. Information regarding adverse events that occurred in the 6 month post-

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vaccination time period was obtained from participants via telephone contact. At least 96% of

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participants completed the 6-month follow-up evaluation.

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Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

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Solicited Adverse Events in the US Adolescent and Adult Study (Td506)

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The frequency of selected solicited adverse events (erythema, swelling, pain and fever) occurring

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during days 0-14 following vaccination with Adacel vaccine or Td vaccine in adolescents 11

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through 17 years of age and adults 18 through 64 years of age are presented in Table 1. Most of

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these events were reported at a similar frequency in recipients of both Adacel vaccine and Td

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vaccine. Pain at the injection site was the most common adverse reaction in 62.9% to 77.8% of all

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vaccinees. In addition, overall rates of pain were higher in adolescent recipients of Adacel vaccine

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compared to Td vaccine recipients. Rates of moderate and severe pain in adolescents did not

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significantly differ between the Adacel vaccine and Td vaccine groups. Among adults the rates of

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pain, after receipt of Adacel vaccine or Td vaccine, did not significantly differ. Fever of 38°C and

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higher was uncommon, although in the adolescent age group, it occurred significantly more

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frequently in Adacel vaccine recipients than Td vaccine recipients.

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Sanofi Pasteur 306 – Adacel®

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Full Prescribing Information

Table 1: Frequencies of Solicited Injection Site Reactions and Fever for Adolescents and Adults, Days 0-14, Following Vaccination With Adacel Vaccine or Td Vaccine in Study Td506 Adolescents

Adults

11-17 years Adacel

Td

N = 1,170-1,175 (%)



Adverse Event*

18-64 years ‡



Adacel

Td

N = 783-787

N = 1,688-1,698

N = 551-561

(%)

(%)

(%)



§





77.8

71.0

65.7

62.9

18.0

15.6

15.1

10.2

1.5

0.6

1.1

0.9

20.9

18.3

21.0

17.3

6.5

5.7

7.6

5.4

≥3.5 cm

6.4

5.5

5.8

5.5

≥5 cm (2 inches)

2.8

3.6

3.2

2.7

20.8

19.7

24.7

21.6

5.9

4.6

8.0

8.4

≥3.5 cm

6.0

5.3

6.2

4.8

≥5 cm (2 inches)

2.7

2.9

4.0

3.0

5.0§

2.7

1.4

1.1

0.9

0.6

0.4

0.2

0.2

0.1

0.0

0.2

Injection

Any

Site

Moderate

Pain

Severe

**

††

Any Moderate** Injection

1.0 to 3.4 cm

Site Swelling

Severe

††

Any Moderate** Injection

1.0 to 3.4 cm

Site Erythema

Severe

††

≥38.0°C (≥100.4°F) Fever

≥38.8°C to ≤39.4°C (≥102.0°F to ≤103.0°F) ≥39.5°C (≥103.1°F)

* † ‡

The study sample size was designed to detect >10% differences between Adacel and Td vaccines for events of ‘Any’ intensity. N = number of participants with available data. Tetanus and Diphtheria Toxoids Adsorbed for Adult Use manufactured by Sanofi Pasteur Inc., Swiftwater, PA.

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Sanofi Pasteur 306 – Adacel®

Full Prescribing Information

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Adacel vaccine did not meet the non-inferiority criterion for rates of ‘Any’ Pain in adolescents compared to Td vaccine rates (upper limit of the 95% CI on the difference for Adacel vaccine minus Td vaccine was 10.7% whereas the criterion was