Vaccine Information: TENIVAC

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

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

2.1 Primary Immunization

In persons who have not been immunized previously against tetanus and diphtheria, primary immunization with TENIVAC consists of three 0.5 mL doses. The first 2 doses are administered 2 months apart and the third dose is administered 6-8 months after the second dose.

TENIVAC may be used to complete the primary immunization series for tetanus and diphtheria, following 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 TENIVAC in such regimens have not been evaluated.

2.2 Routine Booster Immunization

TENIVAC may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.

2.3 Diphtheria Prophylaxis for Case Contacts

TENIVAC 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 recommendations of the Advisory Committee on Immunization Practices for additional interventions for diphtheria prophylaxis in close contacts of diphtheria patients. (1)

2.4 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. (1) TENIVAC 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 passive immunization with Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient’s vaccination history. (See Table 1.)

When indicated, TIG (Human) should be administered at a separate site, with a separate needle and syringe, according to the manufacturer’s package insert. If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given. (1)

Table 1: Guide for use of Tetanus and Diphtheria Toxoids Adsorbed (Td) for Tetanus Prophylaxis in Routine Wound Management in 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, puncture wounds and traumatic wounds.
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 last dose.
§
Yes, if >5 years since last dose. (More frequent boosters are not needed and can accentuate side effects.)
Unknown or < three Yes No Yes Yes
≥ Three No No No § No

2.5 Administration

Just before use, shake the single-dose 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 these conditions exist, the product should not be administered.

Administer the 0.5 mL dose of TENIVAC intramuscularly. Discard unused portion.

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

Do not administer this product intravenously or subcutaneously.

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

3 DOSAGE FORMS AND STRENGTHS

TENIVAC is a suspension for injection available in 0.5 mL single-dose vials or syringes. [See Description (11).]

4 CONTRAINDICATIONS

4.1 Hypersensitivity

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of TENIVAC or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of TENIVAC. [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.

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

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.

5.2 Latex

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

5.3 Frequency of Administration

More frequent doses of TENIVAC than described in Section 2, Dosage and Administration, may be associated with increased incidence and severity of adverse reactions. [See Dosage and Administration (2.1, 2.2, 2.3, 2.4).]

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 TENIVAC more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

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. (2) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give TENIVAC or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

5.6 Limitations of Vaccine Effectiveness

Vaccination with TENIVAC may not protect all individuals.

5.7 Altered Immunocompetence

If TENIVAC is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Drug Interactions (7.3).]

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

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.

In a primary immunization study conducted in Canada, 18 participants, 8 of whom were 6 to 9 years of age and 10 of whom were 17 to 56 years of age, received three doses of TENIVAC. In four booster immunization studies conducted in either the US or Canada, TENIVAC was administered to 3,723 participants overall, ranging in age from 11 to 93 years.

In one of these studies, a US multi-center booster immunization study (TDC01), 2,250 adolescents and adults ages 11-59 years of age received TENIVAC in an open-label design and adults 60 years of age and over were randomized to receive either TENIVAC (N = 700) or DECAVAC (Td manufactured by Sanofi Pasteur Inc.) (N = 701). Vaccine assignment for participants ≥60 years of age was unblinded to pharmacists and vaccination nurses, but was blinded to other study personnel and participants. Among participants who received TENIVAC, overall, 80.4% were Caucasian, 3.3% Black, 5.1% Hispanic, 4.5% Asian and 6.6% other races. Among participants ≥60 years of age, the racial distribution was similar for the TENIVAC and DECAVAC groups. Among participants who received TENIVAC, the proportion of participants who were female varied by age group (44.4% of participants 11-18 years of age, 70.1% of participants 19-59 years of age and 62.4% of participants ≥60 years of age). Among participants ≥60 years of age who received DECAVAC, 57.6% were female. Nearly all (99.8%) enrolled participants and all participants in the per-protocol immunogenicity population had a reported or documented history of previous immunization against tetanus and diphtheria and, by report, had not received a vaccine containing tetanus or diphtheria toxoid within 5 years prior to enrollment.

In the US multi-center booster immunization study, solicited injection site reactions and systemic adverse events were monitored on diary cards for a subset of participants 11-59 years of age and for all participants ≥60 years of age. The incidence and severity of solicited injection site reactions and selected solicited systemic adverse events that occurred within 3 days following vaccination are shown in Table 2.

Table 2: Frequency and Severity of Selected Solicited Adverse Events Within 0-3 Days Following TENIVAC or DECAVAC in a US Study
TENIVAC DECAVAC
Adolescents11 to 18 yearsN = 491-492% Adults19 to 59 yearsN = 247% Adults≥60 yearsN = 688-695% Adults≥60 yearsN = 686-693%
*
Moderate: interfered with activities, but did not require medical care or absenteeism.
Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
Injection Site Adverse Reactions
Pain
Any 80.1 74.9 35.3 29.4
Moderate * 15.0 18.2 2.9 2.3
Severe 0.2 0.4 0.6 0.7
Redness
Any 25.6 15.8 18.1 18.0
≥35 mm to <50 mm 1.2 2.4 0.7 1.3
≥50 mm 0.4 0.4 2.3 1.9
Swelling
Any 15.0 17.0 12.1 13.0
≥35 mm to <50 mm 1.2 2.8 1.0 1.3
≥50 mm 1.8 2.8 1.7 1.3
Systemic Adverse Events
Fever
≥37.5°C 4.3 5.7 2.5 3.8
≥38.0°C to <39°C 0.8 1.6 0.6 0.9
≥39°C 0.0 0.0 0.1 0.1
Headache
Any 23.0 25.1 11.7 10.8
Moderate * 4.3 7.3 1.6 1.4
Severe 0.6 0.8 0.0 0.3
Muscle Weakness
Any 32.3 17.4 4.9 5.9
Moderate * 7.3 3.2 1.3 1.0
Severe 0.6 0.4 0.1 0.1
Malaise
Any 14.5 17.0 8.9 8.8
Moderate * 3.5 3.2 2.4 1.2
Severe 0.8 0.4 0.1 0.4
Pain in Joints
Any 15.7 10.9 8.5 7.4
Moderate * 2.8 1.6 2.2 1.4
Severe 0.6 0.4 0.1 0.0

In the US booster immunization study, among participants ≥60 years of age, 7 (1.0%) participants in the TENIVAC group and 10 (1.4%) participants in the DECAVAC group experienced a serious adverse event within 30 days following vaccination. During this period, 2 (0.3%) participants 19-59 years of age and no participants 11-18 years of age experienced a serious adverse event following TENIVAC. Serious adverse events within 30 days following TENIVAC included localized infection, asthma, colonic polyp, cellulitis, angina pectoris, hip and wrist fracture, cholecystitis, chest pain and cerebrovascular accident.

There were five deaths reported during the study. All of the reported deaths were in participants ≥60 years of age and occurred >30 days post-vaccination: three in the TENIVAC group (cardiopulmonary arrest; myocardial infarction and septic shock; and unknown cause) and two in the DECAVAC group (myocardial infarction and congestive heart failure; and liver cancer).

In the primary immunization study (N = 18) in which serious adverse events were monitored for 3 days following each vaccination and in three other booster immunization studies in which serious adverse events were monitored for either four days (N = 347) or one month (N = 426) following vaccination, no serious adverse events were reported.

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