Vaccine Information: Adacel TDaP TDaP

ADACEL TDAP TDAP- bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated), bordetella pertussis fimbriae 2/3 antigen, bordetella pertussis pertactin antigen, bordetella pertussis toxoid antigen (glutaraldehyde inactivated), clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) injection, suspension
REMEDYREPACK INC.

INDICATIONS & USAGE

Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel vaccine is approved for use as a single dose in individuals 10 through 64 years of age.

DOSAGE & ADMINISTRATION

  • A single intramuscular injection of 0.5 mL. (2.1)

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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

When withdrawing a dose from a stoppered vial, do not remove either the stopper or the metal seal holding it in place. Use a separate sterile needle and syringe for each injection. Using a sterile needle and syringe, withdraw the 0.5 mL dose of vaccine from the single-dose vial and administer the vaccine to the individual. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.

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

Adacel vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm.

Do not administer this product intravenously, subcutaneously or intradermally.

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

Five years should have elapsed since the recipient’s last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine and the administration of Adacel vaccine.

Primary series: The safety and effectiveness of Adacel vaccine used as a primary series or to complete the primary series, for diphtheria, tetanus, or pertussis has not been demonstrated.

Wound management: If tetanus prophylaxis is needed for wound management, Adacel may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.

DOSAGE FORMS & STRENGTHS

Adacel vaccine is a suspension for injection (0.5 mL dose) available in 0.5 mL single-dose vials and prefilled syringes. [See DOSAGE AND ADMINISTRATION (2.2) and HOW SUPPLIED/STORAGE AND HANDLING (16).]

CONTRAINDICATIONS

  • Severe allergic reaction (eg, anaphylaxis) to any component of Adacel or any other diphtheria toxoid, tetanus toxoid and pertussis antigen-containing vaccine. (4.1)
  • Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)

A severe allergic reaction (eg, anaphylaxis) after a previous dose of any tetanus toxoid, diphtheria toxoid or pertussis containing vaccine or any other component of this vaccine is a contraindication to administration of Adacel vaccine. [See DESCRIPTION (11).] Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Encephalopathy (eg, coma, prolonged seizures, or decreased level of consciousness) within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindication to administration of any pertussis containing vaccine, including Adacel vaccine.

WARNINGS AND PRECAUTIONS

  • The tip caps of the Adacel prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. (5.2, 17)
  • If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following a subsequent dose of Adacel vaccine. (5.3)
  • Progressive or unstable neurologic conditions are reasons to defer Adacel vaccination. (5.4)
  • Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)
  • 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)

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

The tip caps of the Adacel prefilled syringe may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. The vial stopper is not made with natural rubber latex. [ See HOW SUPPLIED/STORAGE AND HANDLING (16).]

A review by the Institute of Medicine found evidence for acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (1) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following a dose of Adacel vaccine.

Progressive or unstable neurologic conditions are reasons to defer Adacel. It is not known whether administration of Adacel to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of Adacel to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid containing vaccine.

If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Drug Interactions (7.2).]

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.

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).

To report SUSPECTED ADVERSE REACTIONS, contact Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events. As with any vaccine, there is the possibility that broad use of Adacel vaccine could reveal adverse reactions not observed in clinical trials.

The safety of Adacel vaccine was evaluated in 5 clinical studies. A total of 7,143 individuals 10 through 64 years of age inclusive (4,695 adolescents 10 through 17 years of age and, 2,448 adults 18 through 64 years of age) received a single dose of Adacel vaccine.

Clinical study Td506 was a randomized, observer-blind, active controlled trial that enrolled adolescents 11 through 17 years of age (Adacel vaccine N = 1,184; Td vaccine N = 792) and adults 18 through 64 years of age (Adacel vaccine N = 1,752; Td vaccine N = 573). Study participants had not received tetanus or diphtheria containing vaccines within the previous 5 years. Solicited local and systemic reactions and unsolicited adverse events were monitored daily for 14 days post-vaccination using a diary card. From days 14-28 post-vaccination, information on adverse events necessitating a medical contact, such as a telephone call, visit to an emergency room, physician’s office or hospitalization, was obtained via telephone interview or at an interim clinic visit. From days 28 to 6 months post-vaccination, participants were monitored for unexpected visits to a physician’s office or to an emergency room, onset of serious illness and hospitalizations. Information regarding adverse events that occurred in the 6 month post-vaccination time period was obtained from participants via telephone contact. At least 96% of participants completed the 6-month follow-up evaluation.

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

The frequency of selected solicited adverse events (erythema, swelling, pain and fever) occurring during days 0-14 following vaccination with Adacel vaccine or Td vaccine in adolescents 11 through 17 years of age and adults 18 through 64 years of age are presented in Table 1. Most of these events were reported at a similar frequency in recipients of both Adacel vaccine and Td vaccine. Pain at the injection site was the most common adverse reaction in 62.9% to 77.8% of all vaccinees. In addition, overall rates of pain were higher in adolescent recipients of Adacel vaccine compared to Td vaccine recipients. Rates of moderate and severe pain in adolescents did not significantly differ between the Adacel vaccine and Td vaccine groups. Among adults the rates of pain, after receipt of Adacel vaccine or Td vaccine, did not significantly differ. Fever of 38°C and higher was uncommon, although in the adolescent age group, it occurred significantly more frequently in Adacel vaccine recipients than Td vaccine recipients.

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
Adverse Event * Adolescents11-17 years Adults18-64 years
AdacelN = 1,170-1,175 (%) Td N 2 = 783-787 (%) AdacelN 2 = 1,688-1,698 (%) Td 3N 2 = 551-561(%)
Injection Site Pain Any 77.8§ 71.0 65.7 62.9
Moderate 18.0 15.6 15.1 10.2
Severe # 1.5 0.6 1.1 0.9
Injection Site Swelling Any 20.9 18.3 21.0 17.3
Moderate 5
1.0 to 3.4 cm 6.5 5.7 7.6 5.4
Severe 6
≥3.5 cm 6.4 5.5 5.8 5.5
≥5 cm (2 inches) 2.8 3.6 3.2 2.7
Injection Site Erythema Any 20.8 19.7 24.7 21.6
Moderate 5
1.0 to 3.4 cm 5.9 4.6 8.0 8.4
Severe 6
≥3.5 cm 6.0 5.3 6.2 4.8
≥5 cm (2 inches) 2.7 2.9 4.0 3.0
Fever ≥38.0°C (≥100.4°F) 5.04 2.7 1.4 1.1
≥38.8°C to ≤39.4°C(≥102.0°F to ≤103.0°F) 0.9 0.6 0.4 0.2
≥39.5°C (≥103.1°F) 0.2 0.1 0.0 0.2

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The frequency of other solicited adverse events (days 0-14) are presented in Table 2. The rates of these events following Adacel vaccine were comparable with those observed with Td vaccine. Headache was the most frequent systemic reaction and was usually of mild to moderate intensity.

Table 2: Frequencies of Other Solicited Adverse Events for Adolescents and Adults, Days 0-14, Following Vaccination With Adacel Vaccine or Td Vaccine in Study Td506
Adverse Event Adolescents 11-17 years Adults 18-64 years
AdacelN * = 1,174-1,175 (%) Td N 7 = 787 (%) AdacelN 7 = 1,697-1,698 (%) Td 8N 7 = 560-561 (%)
Headache Any 43.7 40.4 33.9 34.1
Moderate 14.2 11.1 11.4 10.5
Severe § 2.0 1.5 2.8 2.1
Body Ache or Muscle Weakness Any 30.4 29.9 21.9 18.8
Moderate 9 8.5 6.9 6.1 5.7
Severe 10 1.3 0.9 1.2 0.9
Tiredness Any 30.2 27.3 24.3 20.7
Moderate 9 9.8 7.5 6.9 6.1
Severe 10 1.2 1.0 1.3 0.5
Chills Any 15.1 12.6 8.1 6.6
Moderate 9 3.2 2.5 1.3 1.6
Severe 10 0.5 0.1 0.7 0.5
Sore and Swollen Joints Any 11.3 11.7 9.1 7.0
Moderate 9 2.6 2.5 2.5 2.1
Severe 10 0.3 0.1 0.5 0.5
Nausea Any 13.3 12.3 9.2 7.9
Moderate 9 3.2 3.2 2.5 1.8
Severe 10 1.0 0.6 0.8 0.5
Lymph Node Swelling Any 6.6 5.3 6.5 4.1
Moderate 9 1.0 0.5 1.2 0.5
Severe 10 0.1 0.0 0.1 0.0
Diarrhea Any 10.3 10.2 10.3 11.3
Moderate 9 1.9 2.0 2.2 2.7
Severe 10 0.3 0.0 0.5 0.5
Vomiting Any 4.6 2.8 3.0 1.8
Moderate 9 1.2 1.1 1.0 0.9
Severe 10 0.5 0.3 0.5 0.2
Rash Any 2.7 2.0 2.0 2.3

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Injection site and systemic solicited reactions occurred at similar rates in Adacel vaccine and Td vaccine recipients in the 3 day post-vaccination period. Most injection site reactions occurred within the first 3 days after vaccination (with a mean duration of less than 3 days). The rates of unsolicited adverse events reported from days 14-28 post-vaccination were comparable between the two vaccine groups, as were the rates of unsolicited adverse events from day 28 through 6 months. There were no spontaneous reports of extensive limb swelling of the injected limb in study Td506, nor in the other three studies which also contributed to the safety database for Adacel vaccine.

Injection Site and Systemic Reactions When Given With Hepatitis B Vaccine

In the concomitant vaccination study with Adacel and Hepatitis B vaccines [see Clinical Studies (14)], injection site and systemic adverse events were monitored daily for 14 days post-vaccination using a diary card. Injection site adverse events were only monitored at site/arm of Adacel vaccine administration. Unsolicited reactions (including immediate reactions, serious adverse events and events that elicited seeking medical attention) were collected at a clinic visit or via telephone interview for the duration of the trial, ie, up to 6 months post-vaccination.

The rates reported for fever and injection site pain (at the Adacel vaccine administration site) were similar when Adacel and Hep B vaccines were given concurrently or separately. However, the rates of injection site erythema (23.4% for concomitant vaccination and 21.4% for separate administration) and swelling (23.9% for concomitant vaccination and 17.9% for separate administration) at the Adacel vaccine administration site were increased when co-administered. Swollen and/or sore joints were reported by 22.5% for concomitant vaccination and 17.9% for separate administration. The rates of generalized body aches in the individuals who reported swollen and/or sore joints were 86.7% for concomitant vaccination and 72.2% for separate administration. Most joint complaints were mild in intensity with a mean duration of 1.8 days. The incidence of other solicited and unsolicited adverse events were not different between the 2 study groups.

Injection Site and Systemic Reactions When Given With Trivalent Inactivated Influenza Vaccine (TIV)

In the concomitant vaccination study with Adacel vaccine and trivalent inactivated influenza vaccine [see Clinical Studies (14)], injection site and systemic adverse events were monitored for 14 days post-vaccination using a diary card. All unsolicited reactions occurring through day 14 were collected. From day 14 to the end of the trial, ie, up to 84 days, only events that elicited seeking medical attention were collected.

The rates of fever and injection site erythema and swelling were similar for recipients of concurrent and separate administration of Adacel vaccine and TIV. However, pain at the Adacel vaccine injection site occurred at statistically higher rates following concurrent administration (66.6%) versus separate administration (60.8%). The rates of sore and/or swollen joints were 13% for concurrent administration and 9% for separate administration. Most joint complaints were mild in intensity with a mean duration of 2.0 days. The incidence of other solicited and unsolicited adverse events were similar between the 2 study groups.

Additional Studies

In an additional study, 1,806 adolescents 11 through 17 years of age received Adacel vaccine as part of the lot consistency study used to support Adacel vaccine licensure. This study was a randomized, double-blind, multi-center trial designed to assess lot consistency as measured by the safety and immunogenicity of 3 lots of Adacel vaccine when given as a booster dose to adolescents 11 through 17 years of age inclusive. Local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination. Pain was the most frequently reported local adverse event occurring in approximately 80% of all participants. Headache was the most frequently reported systemic event occurring in approximately 44% of all participants. Sore and/or swollen joints were reported by approximately 14% of participants. Most joint complaints were mild in intensity with a mean duration of 2.0 days.

An additional 962 adolescents and adults received Adacel vaccine in three supportive Canadian studies used as the basis for licensure in other countries. Within these clinical trials, the rates of local and systemic reactions following Adacel vaccine were similar to those reported in the four principal trials in the US with the exception of a higher rate (86%) of adults experiencing ‘any’ local injection site pain. The rate of severe pain (0.8%), however, was comparable to the rates reported in four principal trials conducted in the US. There was one spontaneous report of whole-arm swelling of the injected limb among the 277 Td vaccine recipients, and two spontaneous reports among the 962 Adacel vaccine recipients in the supportive Canadian studies.

An additional study, Td519, enrolled 1,302 individuals in an open label, two-arm, multi-center trial (651subjects in each group) to evaluate the safety and immunogenicity of a single dose of Adacel administered to persons 10 to < 11 years of age compared to persons 11 to < 12 years of age. Immediate reactions were monitored for 20 minutes post-vaccination. Solicited local and systemic adverse events were monitored for 7 days post-vaccination using a diary card. Unsolicited and serious adverse events were collected for approximately 30 days post-vaccination. Similar rates of immediate, solicited and unsolicited adverse reactions were reported in each of the two age cohorts. One serious adverse event, not related to vaccination, was reported in the younger age group.

Serious Adverse Events in All Safety Studies

In all the studies, participants were monitored for serious adverse events throughout the duration of the study.

Throughout the 6-month follow-up period in study Td506, serious adverse events were reported in 1.5% of Adacel vaccine recipients and in 1.4% of Td vaccine recipients. Two serious adverse events in adults were neuropathic events that occurred within 28 days of Adacel vaccine administration; one severe migraine with unilateral facial paralysis and one diagnosis of nerve compression in neck and left arm. Similar or lower rates of serious adverse events were reported in the other trials in participants up to 64 years of age and no additional neuropathic events were reported.

The following adverse events of Adacel have been spontaneously reported in the US and other countries. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following 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 Adacel vaccine.

  • Immune system disorders
    Anaphylactic reaction, hypersensitivity reaction (angioedema, edema, rash, hypotension)
  • Nervous system disorders
    Paraesthesia, hypoesthesia, Guillain-Barré syndrome, brachial neuritis, facial palsy, convulsion, syncope, myelitis
  • Cardiac disorders
    Myocarditis
  • Skin and subcutaneous tissue disorders
    Pruritus, urticaria
  • Musculoskeletal and connective tissue disorders
    Myositis, muscle spasm
  • General disorders and administration site conditions
    Large injection site reactions (>50 mm), extensive limb swelling from the injection site beyond one or both jointsInjection site bruising, sterile abscess
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