Indications for: TENIVAC

Tetanus and diphtheria immunization in patients ≥7yrs.

Clinical Trials:

Primary Immunization

  • A study conducted in Canada evaluated the 3-dose primary immunization series with Tenivac in 17 patients 6 to 56 years of age. Patients received the first 2 doses administered 2 months apart, followed by a third dose at 6 to 8 months after the second dose.

  • All patients achieved a serum tetanus antitoxin level >0.1 IU/mL and a serum diphtheria antitoxin level ≥0.01 IU/mL after 4 weeks following the second dose.

  • All patients achieved a serum diphtheria antitoxin level >0.1 IU/mL after 4 weeks following the third dose.

Booster Immunization

  • The immune response of Tenivac was evaluated in the US multicenter booster immunization study (TDC01) in a subset of participants 11 to 59 years of age, and compared to Decavac in participants ≥60 years of age who were randomly assigned to receive a dose of either Tenivac or Decavac. 

  • See full labeling for tetanus antitoxoid levels and booster response rates following a dose of Tenivac by age group.

Adults and Children:

<7yrs: not established. ≥7yrs: Give IM in deltoid muscle. Previously unvaccinated: three 0.5mL doses, administer first two doses 2 months apart and then third dose 6–8 months after second dose. Routine booster: give at 11–12yrs of age and every 10 years thereafter. Diphtheria and tetanus prophylaxis: see full labeling.

TENIVAC Contraindications:

Anaphylaxis associated with a previous dose.

TENIVAC Warnings/Precautions:

Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid vaccine. Previous Arthus-type hypersensitivity reaction: not recommended until ≥10yrs after prior dose of tetanus toxoid-containing vaccine. Immunodeficiency. Have epinephrine (1:1000) available. Latex allergy (syringe tip cap). Pregnancy (Cat.C). Nursing mothers.

TENIVAC Classification:

Td vaccine.

TENIVAC Interactions:

Concomitant tetanus immune globulin (human): inject at separate site with separate needle and syringe if passive protection required. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

Adverse Reactions:

Injection site reactions (eg, pain, redness, swelling), headache, malaise, muscle weakness, joint pain; syncope.

How Supplied:

Single-dose vials (0.5mL)—10
Single-dose prefilled syringe (0.5mL)—10