TT vax40 IU/0.5 ml

TT vax is a toxoid vaccine used for active immunization against tetanus, a serious disease caused by the toxin of Clostridium tetani.

Established / guideline-supported uses

• Primary immunization series against tetanus in infants, children, adolescents, and adults, generally given as part of a combination diphtheria-tetanus-containing vaccine, or alone when only tetanus protection is required.
• Booster (recall) doses to maintain protective antitoxin levels, typically every 10 years after completion of the primary series.
• Tetanus prophylaxis in wound management, given after injury (e.g. puncture wounds, burns, contaminated wounds) according to the wound type and the person's prior vaccination history, sometimes together with tetanus immunoglobulin for wounds at higher risk.
• Maternal immunization during pregnancy as part of national/WHO programs to prevent maternal and neonatal tetanus.

TT vax is a preventive (prophylactic) vaccine only; it is not used to treat an established tetanus infection, which requires tetanus immunoglobulin and supportive medical care.

Each single (0.5 mL) dose of Adsorbed Tetanus Vaccine contains purified tetanus toxoid, derived from inactivated (formaldehyde-treated) tetanus toxin, adsorbed onto an aluminium-salt adjuvant (aluminium phosphate or aluminium hydroxide) to enhance and prolong the immune response.

The formulation may contain a preservative (e.g. thiomersal) in multi-dose presentations, and trace amounts of formaldehyde and aluminium salts from the manufacturing process. Exact excipients vary by manufacturer/brand; refer to the specific product leaflet for the marketed brand.

TT vax is an injectable vaccine that provides active immunity against tetanus. It contains tetanus toxoid - the inactivated form of the toxin produced by Clostridium tetani - adsorbed onto an aluminium-based adjuvant that improves the strength and duration of the immune response.

Tetanus is a life-threatening but entirely preventable disease characterized by muscle rigidity and painful spasms, caused by a neurotoxin (tetanospasmin). Because the organism is present in soil, dust, and animal manure, immunization with TT vax is the primary method of prevention, complemented by proper wound care.

Vaccines - Toxoid vaccine (active immunizing agent against tetanus)

Adsorbed Tetanus Vaccine works by inducing active immunity. The tetanus toxoid it contains is immunologically similar to the natural tetanus toxin but has lost its toxic (neurotoxic) properties through inactivation, while retaining the ability to stimulate the immune system.

Following intramuscular injection, antigen-presenting cells process the toxoid and present it to the immune system, stimulating B-lymphocytes to produce specific anti-tetanus toxin antibodies (antitoxin) and generating immunological memory through memory B- and T-cells. The aluminium adjuvant in Adsorbed Tetanus Vaccine creates a local antigen depot and enhances antigen presentation, producing a stronger and longer-lasting antibody response than toxoid alone.

A protective antitoxin level (generally accepted as ≥0.01-0.1 IU/mL) is achieved after completion of the primary series, and is maintained/boosted by subsequent recall doses of Adsorbed Tetanus Vaccine.

TT vax is for intramuscular (IM) injection only.

• Preferred injection site: the anterolateral thigh in infants, and the deltoid muscle of the upper arm in older children, adolescents, and adults.
• Shake the vial/syringe well before use to ensure a uniform suspension; do not use if particulate matter, discoloration, or unusual clumping is present.
• Do not administer intravenously or subcutaneously; do not inject into the gluteal region due to risk of reduced immune response and sciatic nerve injury.
• Use a separate syringe, needle, and injection site for each vaccine if given at the same visit as other vaccines/immunoglobulins.
• Should be administered by a trained healthcare professional under conditions where treatment for a rare acute anaphylactic reaction is available.

TT vax can generally be given at the same time as other routinely recommended vaccines, using separate syringes and separate injection sites.

• Immunosuppressive therapy (e.g. high-dose corticosteroids, chemotherapy, biologic immunosuppressants) or immunodeficiency states: may blunt the antibody response to TT vax; vaccination may need to be deferred or the person may require re-vaccination/serologic testing once immune function improves.
• Tetanus immunoglobulin (TIG) or other blood products/immunoglobulins: can be given concurrently with TT vax for wound prophylaxis, but must be given at a different injection site with a different syringe; recent receipt of immunoglobulin/blood products may reduce the immune response if given very close together.
• Other tetanus-toxoid-containing vaccines: avoid unnecessary extra doses given close together, as this increases the risk of local (Arthus-type) hypersensitivity reactions - see Precautions and Warnings.

Most reactions to TT vax are mild and self-limited.

Common

• Injection-site pain, redness, swelling, or induration (the most frequently reported reaction)
• Low-grade fever, malaise, headache, myalgia/arthralgia, and fatigue

Uncommon/Rare

• Large local (Arthus-type) reactions, more common with frequent boosters given closer together than recommended
• Urticaria and other hypersensitivity reactions
• Transient lymphadenopathy
• Syncope (vasovagal reaction) around the time of injection, mainly in adolescents

Very rare/serious

• Anaphylaxis (severe allergic reaction) - see Contraindications
• Guillain-Barré syndrome and brachial neuritis have been reported very rarely in temporal association with tetanus-toxoid-containing vaccines - see Precautions and Warnings

Pregnancy: TT vax is a widely used component of maternal immunization programs, since maternal tetanus antibodies cross the placenta and protect the newborn from neonatal tetanus. Vaccination in pregnancy is generally recommended by health authorities for this purpose; nonetheless, as with any medicine or vaccine, it should be given based on clinical assessment, and the potential benefit should be weighed against any risk - use only as advised by a physician or the national immunization program.

Lactation: TT vax is considered compatible with breastfeeding; there is no evidence of harm to a nursing infant, and breastfeeding mothers can be vaccinated per the standard schedule.

• Acute illness: defer non-urgent doses of TT vax in individuals with moderate or severe acute illness (with or without fever) until recovery; minor illnesses (e.g. mild upper respiratory infection) are not a reason to delay.
• Guillain-Barré syndrome (GBS): in a person with a history of GBS within 6 weeks of a previous dose of a tetanus-toxoid-containing vaccine, the decision to give further doses of TT vax should be based on careful assessment of the expected benefits against the risk of recurrence.
• History of Arthus-type hypersensitivity reaction or of a severe local reaction after a previous tetanus-toxoid-containing vaccine: further doses of TT vax should generally not be given more frequently than every 10 years.
• Bleeding disorders/anticoagulant therapy: give with caution using a fine-gauge needle with firm pressure applied to the injection site, because of the risk of bleeding/haematoma.
• Syncope: vasovagal episodes can occur after injection, particularly in adolescents; observe recipients for a short period after vaccination.
• As with all injectable vaccines, appropriate medical treatment for a rare anaphylactic reaction must be immediately available whenever TT vax is administered.

There is no clinically established "overdose" syndrome for TT vax in the sense of a drug overdose. Administration of doses more frequently, or in larger amounts, than recommended may increase the risk of local (Arthus-type) hypersensitivity reactions and other injection-site reactions rather than causing systemic toxicity.

If a dose of TT vax greater than recommended is inadvertently given, or if any severe or worrying reaction occurs after vaccination, seek immediate medical attention or contact emergency services/a poison control centre; do not attempt to manage a severe reaction at home.

Store TT vax in a refrigerator at 2°C to 8°C. Do not freeze - freezing destroys the aluminium-adjuvanted suspension and reduces effectiveness; discard if the vaccine has been frozen. Protect from light, keep in the original carton until the time of use, and keep out of reach of children. Discard any unused portion of a multi-dose vial as per local guidelines/product labelling after opening.

• Immunocompromised individuals (e.g. HIV infection, chemotherapy, high-dose corticosteroids, organ transplant): TT vax can generally still be given, as it is not a live vaccine, but the antibody response may be reduced; serologic testing or additional doses may be considered after immune recovery.
• Elderly patients: no dose adjustment is required; ensuring an up-to-date booster is particularly important as antitoxin levels can wane with age.
• Renal or hepatic impairment: no specific dose adjustment is established or generally required for TT vax.
• Pregnant women: see Pregnancy and Lactation.

TT vax is not used as a continuous "treatment" but as a course of immunization. The primary series should be completed on schedule to establish protective immunity, and booster doses of TT vax should then be repeated approximately every 10 years (or sooner for high-risk wounds) to maintain lifelong protection, since antitoxin levels decline over time without periodic boosting.

Toxoid vaccines; Active immunizing agents (tetanus)

Adsorbed Tetanus Vaccine contains tetanus toxoid - tetanus toxin that has been chemically inactivated so it can no longer cause disease but still triggers an immune response. Adsorption onto an aluminium adjuvant slows release of the antigen at the injection site and enhances uptake by antigen-presenting cells, producing a stronger, longer-lived immune response than plain (non-adsorbed) toxoid.

This stimulates B-lymphocytes (with T-helper cell support) to produce neutralizing anti-tetanus antibodies (antitoxin) and generates immunological memory, so that on re-exposure to tetanus toxin - or on receipt of a booster dose of Adsorbed Tetanus Vaccine - the immune system mounts a rapid, protective secondary antibody response.

TT vax (usually as part of a combination diphtheria-tetanus-containing vaccine in young children) is used from as early as 6 weeks of age as part of the routine national immunization schedule, with a primary series in infancy followed by booster doses in early childhood and adolescence.

Monovalent TT vax (tetanus toxoid alone) is typically reserved for older children (from about 7 years of age) and adults for booster doses or wound prophylaxis, once pertussis- and/or diphtheria-antigen-containing combinations are no longer age-appropriate or preferred. Safety and efficacy of specific brand presentations below the labelled minimum age have not been established; follow the national immunization schedule and product labelling for exact age indications.