TETRAXIM is a combination vaccine that protects against four serious infectious diseases: tetanus, diphtheria, pertussis (whooping cough), and polio (poliomyelitis). It is commonly used as part of the immunization schedule for infants, children, and adults. This vaccine is intended to provide long-term immunity to prevent these potentially life-threatening diseases. It is administered via an intramuscular injection, typically in the upper arm or thigh, depending on the patient’s age. TETRAXIM is often used as part of a routine vaccination series and may be recommended for individuals requiring a booster dose to maintain immunity.

Pharmaceutical Properties:

• Active Ingredients: TETRAXIM contains inactivated bacterial toxins and inactivated poliovirus components:

  • Clostridium tetani (tetanus toxoid)

  • Corynebacterium diphtheriae (diphtheria toxoid)

  • Bordetella pertussis (inactivated pertussis toxoid and other bacterial components)

  • Poliovirus (inactivated poliovirus types 1, 2, and 3).

• Formulation: Each dose of TETRAXIM is 0.5 mL and is delivered through an intramuscular injection. It is presented in a prefilled syringe or vial as a sterile, cloudy or slightly opalescent suspension.

• Appearance: The vaccine should appear as a white, opaque suspension in the syringe or vial. It should be well shaken before administration to ensure proper mixing.

• Storage Conditions: TETRAXIM should be stored in a refrigerator at temperatures between 2°C and 8°C (36°F to 46°F). It should not be frozen, and any unused vaccine should be discarded after the expiration date.

• Excipients: The vaccine contains stabilizers and preservatives to ensure its safety and effectiveness during storage and use.

Indications for Use:

TETRAXIM is indicated for the following:

1. Primary Immunization (Infants and Children): TETRAXIM is recommended for the primary vaccination series in infants and children, typically given in three doses at 2, 4, and 6 months of age. It provides protection against tetanus, diphtheria, pertussis, and polio.

2. Booster Dose for Children and Adults: TETRAXIM is used as a booster vaccination for children aged 4–6 years, adolescents, and adults to maintain immunity against these diseases. A booster dose is typically given every 10 years or after significant exposure to risk factors (e.g., injury).

3. Protection During Pregnancy (for Pertussis): Pregnant women may receive a dose of TETRAXIM during the third trimester to help protect both the mother and newborn from pertussis, which can be fatal in infants.

4. Post-Exposure Vaccination (Tetanus and Polio): TETRAXIM is used for individuals who sustain injuries that put them at risk for tetanus (especially if they have not had a recent booster) and for individuals exposed to poliovirus in areas where it is still a risk.

Mechanism of Action:

TETRAXIM works by stimulating the immune system to produce antibodies against the bacterial toxins responsible for tetanus, diphtheria, and pertussis, as well as the poliovirus.

• Tetanus Toxoid: The tetanus component induces the production of antibodies that neutralize the tetanus toxin, which can cause severe muscle spasms and neurological issues.

• Diphtheria Toxoid: The diphtheria component stimulates the immune system to produce antibodies that protect against the diphtheria toxin, which can lead to severe respiratory issues, heart failure, and nerve damage.

• Pertussis Components: The pertussis component of TETRAXIM helps the immune system develop immunity against Bordetella pertussis, the bacterium responsible for whooping cough. This can prevent severe coughing fits and respiratory issues, which are especially dangerous for infants.

• Inactivated Poliovirus: The poliovirus component in the vaccine contains inactivated poliovirus strains (types 1, 2, and 3). These components stimulate the immune system to produce antibodies against polio, preventing the onset of poliomyelitis, a disease that can lead to paralysis and death.

By priming the immune system with inactivated versions of these pathogens, the body is able to recognize and mount a quick defense against future exposure, reducing the risk of disease development.

Clinical Protocol in Dubai:

1. Patient Selection:

   • Infants and Children: TETRAXIM is recommended for primary immunization in infants aged 2, 4, and 6 months to protect against tetanus, diphtheria, pertussis, and polio.

   • Children (Booster): A booster dose is typically administered at ages 4–6 years to continue protection against these diseases.

   • Adolescents and Adults: A booster dose is recommended every 10 years for individuals who have completed their primary vaccination series to ensure continued immunity.

   • Pregnant Women: TETRAXIM can be given during the third trimester of pregnancy, particularly to protect the newborn from pertussis (whooping cough).

   • Wound Management: TETRAXIM is indicated for individuals who sustain injuries that could put them at risk of tetanus or are exposed to poliovirus.

2. Dosage and Administration:

   • Primary Immunization (Infants and Children): A series of three doses, administered at 2, 4, and 6 months of age.

   • Booster Dose (Children, Adolescents, Adults): A booster dose every 10 years or after potential exposure to risk factors.

   • Pregnancy: One dose of TETRAXIM is recommended during the third trimester (preferably between 27 and 36 weeks of pregnancy).

3. Precautions and Contraindications:

   • Contraindications: TETRAXIM should not be administered to individuals who have had an allergic reaction to any component of the vaccine or to previous doses of the vaccine.

   • Pregnancy: TETRAXIM is considered safe during pregnancy, especially in the third trimester. However, it should only be given when necessary.

   • Acute Illness: Individuals with moderate or severe illness should wait until they recover before receiving the vaccine.

4. Monitoring:

   • Post-Vaccination Monitoring: After the injection, patients should be monitored for 15 minutes for any signs of allergic reactions, especially for anaphylaxis.

   • Common Side Effects: Mild reactions include pain at the injection site, redness, swelling, fever, fatigue, and irritability in children.

   • Rare Side Effects: Serious side effects such as anaphylaxis are rare but require immediate medical intervention.

Other Characteristics:

• Adverse Effects: The most common side effects of TETRAXIM include mild, localized reactions such as swelling, redness, or pain at the injection site. Systemic effects like fever, fatigue, and irritability in children may also occur.

• Efficacy: TETRAXIM is highly effective in preventing tetanus, diphtheria, pertussis, and polio. The vaccine provides long-lasting immunity, and the risk of adverse effects is minimal.

TETRAXIM is a highly effective vaccine that offers combined protection against tetanus, diphtheria, pertussis, and polio. It is an essential component of the immunization schedule for children, adolescents, and adults, ensuring continued immunity against these serious diseases. Pregnant women, healthcare workers, travelers, and individuals with wounds or injuries are also encouraged to receive TETRAXIM to prevent infection. The vaccine is safe, well-tolerated, and plays a crucial role in protecting public health in Dubai and globally.