Vaccine Information: DECAVAC

DECAVAC- clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) suspension
Sanofi Pasteur Inc.

1. INDICATIONS AND USAGE

DECAVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older.

2. DOSAGE AND ADMINISTRATION

2.1. Dosage and Schedule

Primary Immunization

DECAVAC vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria or who have begun a primary immunization series but did not complete it. The primary immunization series consists of three 0.5 mL doses. The first two doses are administered at least 4 weeks apart and the third dose is administered at least 6 months after the second dose.

DECAVAC vaccine may be used to complete the primary immunization series for tetanus and diphtheria in persons 7 years of age or older who have received one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT). However, the safety and efficacy of DECAVAC vaccine in such regimens have not been evaluated.

Routine Booster Immunization

DECAVAC vaccine may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter. (1)

Tetanus Prophylaxis in Wound Management

For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection. (2) DECAVAC vaccine is approved for wound management of patients 7 years of age and older.

The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient’s vaccination history (Table 1).

When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer’s package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given. (2)

Table 1: Guide to Use of Tetanus and Diphtheria Toxoids Adsorbed (Td) and Tetanus Immune Globulin (TIG) (Human) for Tetanus Prophylaxis in Routine Wound Management for Persons 7 Years of Age and Older
History of Adsorbed Tetanus Toxoid (doses) Clean, Minor Wounds All Other Wounds *
Td TIG Td TIG
*
Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite.
If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably, an adsorbed toxoid should be given.
Yes, if ≥10 years since the last tetanus toxoid-containing vaccine dose.
§
Yes, if ≥5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.)
Unknown or <three Yes No Yes Yes
≥three No No No § No

Diphtheria Prophylaxis for Case Contacts

DECAVAC vaccine may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis. (2)

2.2. Administration

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

DECAVAC vaccine, after shaking, is a turbid liquid, whitish-gray in color.

For DECAVAC vaccine supplied in vials, shake the vial well before withdrawing the dose. Discard vial if DECAVAC vaccine cannot be resuspended.

For DECAVAC vaccine supplied in syringes, shake the syringe well before administering the dose. Discard syringe if DECAVAC vaccine cannot be resuspended.

Inject 0.5 mL intramuscularly. The preferred site is the deltoid muscle. DECAVAC vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer DECAVAC vaccine intravenously or subcutaneously.

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

3. DOSAGE FORMS AND STRENGTHS

DECAVAC vaccine is a sterile suspension for injection available in 0.5 mL single-dose vials or syringes.

4. CONTRAINDICATIONS

4.1. Hypersensitivity

A severe allergic reaction (eg, anaphylaxis) after a previous dose of DECAVAC vaccine or any other tetanus toxoid or diphtheria toxoid containing vaccine or any other component of this vaccine is a contraindication to administration of DECAVAC vaccine. [See Description (11).] Because of uncertainty as to which component of the vaccine may be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

5. WARNINGS AND PRECAUTIONS

5.1. Management of Acute Allergic Reactions

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.

5.2. Latex

The tip caps of the DECAVAC prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals.

5.3. Frequency of Administration

More frequent administration of DECAVAC vaccine than described in Dosage and Administration [see Dosage and Administration (2.1)] may be associated with increased incidence and severity of adverse reactions.

5.4. Arthus Reactions

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine usually have high serum tetanus antitoxin levels and should not receive DECAVAC vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management [see Dosage and Administration (2.1)].

5.5. Guillain-Barré Syndrome and Brachial Neuritis

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (3) If Guillain-Barré syndrome occurred within 6 weeks after receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following DECAVAC vaccine.

5.6. Limitations of Vaccine Effectiveness

Vaccination with DECAVAC vaccine may not protect all individuals.

5.7. Altered Immunocompetence

Immune responses to inactivated vaccines and toxoids when given to immunocompromised persons may be suboptimal. The immune response to DECAVAC vaccine administered to immunocompromised individuals (whether from disease or treatment) has not been studied.

6. ADVERSE REACTIONS

6.1. Data from Clinical Studies

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.

6.2. Primary Immunization

In a clinical study, 42 persons 6-58 years of age underwent primary immunization against tetanus and diphtheria. Eight of these participants (19%) noted local reactions consisting of pain and tenderness, induration, and erythema at the injection site; none reported systemic symptoms. (4)

6.3. Booster Immunization

In a clinical study, 792 adolescents 11-17 years of age and 573 adults 18-64 years of age received a booster dose with DECAVAC vaccine. Study participants had not received tetanus or diphtheria toxoid-containing vaccines within the previous 5 years. Solicited local reactions and systemic adverse events were monitored daily for 14 days post-vaccination using subject diary cards. Serious adverse events were monitored through 6 months post-vaccination. Ninety-seven percent of participants who received DECAVAC vaccine completed the 6-month telephone follow-up.

Solicited Adverse Events

The frequency of selected solicited injection site reactions (pain, swelling, or erythema) occurring during Days 0-14 following booster vaccination with DECAVAC vaccine in adolescents 11 through 17 years of age, and adults 18 through 64 years of age are presented in Table 2. Pain at the injection site was the most common adverse reaction occurring in 71% of adolescents and 62.9% of adults.

Table 2: Frequencies of Solicited Injection Site Reactions for Adolescents and Adults, Days 0-14 Following BoosterVaccination with DECAVAC Vaccine
Adverse Event Adolescents11-17 yearsN * = 783-787 (%) Adults18-64 yearsN * = 551-561 (%)
*
N = number of participants who provided data (not all participants evaluated every event).
Interfered with activities, but did not necessitate medical care or absenteeism.
Incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.
Injection Site Pain Any 71.0 62.9
Moderate 15.6 10.2
Severe 0.6 0.9
Injection Site Swelling Any 18.3 17.3
Moderate
1.0 to 3.4 cm 5.7 5.4
Severe
≥3.5 cm 5.5 5.5
≥5 cm 3.6 2.7
Injection Site Erythema Any 19.7 21.6
Moderate
1.0 to 3.4 cm 4.6 8.4
Severe
≥3.5 cm 5.3 4.8
≥5 cm 2.9 3.0

The frequency of solicited systemic adverse events occurring during Days 0-14 following booster vaccination with DECAVAC vaccine are presented in Table 3. Headache was the most frequent solicited systemic adverse event, and was usually of mild or moderate intensity.

Table 3: Frequencies of Solicited Systemic Adverse Events for Adolescents and Adults, Days 0-14 Following Booster Vaccination with DECAVAC Vaccine
Adverse Event Adolescents 11-17 years Adults 18-64 years
N * = 787 (%) N * = 560-561 (%)
*
N = number of participants who provided data (not all participants evaluated every event).
Interfered with activities, but did not necessitate medical care or absenteeism.
Incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism.
Headache Any 40.4 34.1
Moderate 11.1 10.5
Severe 1.5 2.1
Body Ache or MuscleWeakness Any 29.9 18.8
Moderate 6.9 5.7
Severe 0.9 0.9
Tiredness Any 27.3 20.7
Moderate 7.5 6.1
Severe 1.0 0.5
Chills Any 12.6 6.6
Moderate 2.5 1.6
Severe 0.1 0.5
Nausea Any 12.3 7.9
Moderate 3.2 1.8
Severe 0.6 0.5
Sore andSwollenJoints Any 11.7 7.0
Moderate 2.5 2.1
Severe 0.1 0.5
Diarrhea Any 10.2 11.3
Moderate 2.0 2.7
Severe 0.0 0.5
LymphNodeSwelling Any 5.3 4.1
Moderate 0.5 0.5
Severe 0.0 0.0
Vomiting Any 2.8 1.8
Moderate 1.1 0.9
Severe 0.3 0.2
Fever Any ≥38.0°C (≥100.4°F) 2.7 1.1
≥38.8°C to ≤39.4°C(≥102.0°F to ≤103.0°F) 0.6 0.2
≥39.5°C (≥103.1°F) 0.1 0.2
Rash Any 2.0 2.3

Serious Adverse Events

Among 792 adolescents 11-17 years of age and 573 adults 18-64 years of age who received a booster dose with DECAVAC vaccine, 2 adolescents and 2 adults reported a serious adverse event that occurred within 30 days following vaccination. Events reported in adolescents were jaw fracture secondary to trauma and abdominal pain/appendectomy. Events reported in adults were atrial septal defect and elective surgical repair in one subject, and myocardial infarction in one subject with a history of coronary artery disease.

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