This vaccine is indicated for the prevention of diphtheria, tetanus, pertussis and poliomyelitis:

• For primary vaccination in infants from 2 months of age,
• For booster vaccination one year after primary vaccination during the second year of life,
• For booster vaccination between 5 and 13 years of age, according to official recommendations.

One dose (0.5 mL) contains:

• Diphtheria toxoid ≥30 IU
• Tetanus toxoid ≥40 IU

Bordetella pertussis antigens:

• Pertussis toxoid: 25 micrograms
• Filamentous haemagglutinin: 25 micrograms

Poliomyelitis virus (inactivated):

• Type 1 (Mahoney strain): 40 DU
• Type 2 (MEF-1 strain): 8 DU
• Type 3 (Saukett strain): 32 DU

This vaccine must be administered according to the official recommendations in effect. Primary vaccination: 3 injections given at an interval of one month, i.e. according to the official schedule, at the age of 2, 3, 4 months.

Booster vaccination: 1 injection one year after primary vaccination, i.e. usually, between 16 and 18 months. Booster vaccination between 5 and 13 years of age: 1 injection. For primary vaccination and for the first booster dose, this vaccine may be administered by reconstituting the Haemophilus influenzae type b conjugate vaccine (Act-HIB) or administered at the same time as this vaccine, but at two separate injection sites.

Administer via the intramuscular route. Administration should preferably be performed in the antero-lateral side of the thigh (middle third) in infants and in the deltoid area in children

This vaccine may be administered at the same time as the M-M-RVAXPRO vaccine or the HBVAXPRO vaccine, provided that separate injection sites are used. This vaccine can also be administered in association with or combined with the Haemophilus influenzae type b conjugate vaccine (Act-HIB).

Hypersensitivity:

• To any of the active substances of this vaccine,
• To any of the excipients listed in section 6.1,
• To glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during manufacturing and may be present as traces),
• To any pertussis vaccine (acellular or whole cell).

Life-threatening reaction after previous administration of the same vaccine or a vaccine containing similar components. Vaccination should be postponed in case of febrile or acute illness. Evolving encephalopathy.

Encephalopathy within 7 days after administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular).

The safety profile described is based on clinical data from France, South Korea, Chile, and Thailand. In clinical studies involving children receiving TETRAXIM as a primary series, either alone or combined with Act-HIB vaccine, the most commonly reported reactions include local injection-site reactions, abnormal crying, loss of appetite, and irritability. These signs and symptoms usually appear within 48 hours after vaccination and may persist for 48–72 hours. They typically resolve spontaneously without specific treatment. The frequency of injection-site reactions tends to increase with booster doses compared to primary vaccination. The safety profile does not differ significantly across age groups; however, some reactions (such as myalgia, malaise, and headache) are more specific to children aged 2 years or older.

The immune response to this vaccine may be reduced in individuals receiving immunosuppressive therapy or those with immunodeficiency. It is recommended to delay vaccination until the completion of treatment or recovery from illness. However, vaccination is still recommended in individuals with chronic immunodeficiency such as HIV infection, although the immune response may be limited. If Guillain-Barré syndrome or brachial neuritis has occurred following a previous tetanus toxoid-containing vaccine, careful evaluation of the benefits and risks should be made before administering further doses. Vaccination is generally recommended for infants with incomplete primary immunization schedules.

Do not administer via the intravascular route; ensure that the needle does not enter a blood vessel. Do not administer intradermally. As with all injectable vaccines, caution is required in individuals with thrombocytopenia or bleeding disorders due to the risk of bleeding after intramuscular injection.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transportation should also be maintained at +2°C to +8°C. Do not freeze. Discard the solution if frozen. Protect from light.