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Last updated: December 2024
Indications
- Prevention of diphtheria, tetanus, pertussis, hepatitis B and severe Haemophilus influenzae type B (Hib) infections in children from 6 weeks to 7 years of age (primary vaccination)
Composition, forms, route of administration
- Pentavalent vaccine combining diphtheria toxoid, tetanus toxoid, pertussis antigens (whole-cell), hepatitis B surface antigen and Hib polysaccharide
- Suspension for injection in multidose vial, for IM injection into the anterolateral part of the thigh in children < 2 years and into the deltoid muscle in children ≥ 2 years.
DO NOT ADMINISTER INTO THE GLUTEAL MUSCLE. - Shake before use to homogenise the vaccine.
Dosage and vaccination schedule
- Three-dose primary series:
- Child: 3 doses 4 weeks apart, preferably before the age of 6 months. It is recommended to administer the 1st dose at 6 weeks of age, the 2nd dose at 10 weeks of age and the 3rd dose at 14 weeks of age.
- If a child has not received the 1st dose by the age of 1 year, start vaccination as soon as possible according to the 0-1-6 schedule: 2 doses 4 weeks apart, then a 3rd dose 6 months after the 1st dose
- If vaccine schedule has been interrupted, the missing doses should be completed and not restarted from the beginning.
Contra-indications, adverse effects, precautions
- Do not administer in the event of allergic reactions to a previous dose of vaccine containing these strains.
- Do not administer at birth to vaccinate against hepatitis B.
- Vaccination should be postponed in the event of severe acute febrile illness; minor infections are not contra-indications.
- May cause: mild local reactions (redness, pain at the injection site), fever, pain, malaise, headache, myalgia; rarely: anaphylactic reactions.
- If administered simultaneously with other vaccines, use different syringes and injection sites.
Remarks
- Depending on national recommendations, primary vaccination can be done with a trivalent vaccine (diphtheria, tetanus, pertussis), tetravalent vaccine (diphtheria, tetanus, pertussis, hepatitis B), pentavalent vaccine (diphtheria, tetanus, pertussis, Hib, poliomyelitis) or hexavalent vaccine (diphtheria, tetanus, pertussis, hepatitis B, Hib, poliomyelitis).
- A booster dose with a vaccine containing at least diphtheria toxoid, tetanus toxoid and pertussis antigen is recommended between 12 to 23 months of age. Other boosters are recommended between 4 to 7 years of age and 9 to 15 years of age with a bivalent vaccine containing diphtheria and tetanus toxoids.
Storage
– Between 2 °C and 8 °C. Do not freeze.