Type: Combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis, and adsorbed conjugated Haemophilus influenzae type b vaccine
Form: Sterile suspension for injection
Manufacturer: GlaxoSmithKline Inc.
Indications and Clinical Use
Primary Immunization: For active immunization against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b in infants and children from 6 weeks to 2 years of age.
Booster Vaccination: Administered at 12 to 23 months for children who have received a full primary vaccination course with each of the antigens.
Contraindications
Hypersensitivity to any component of the vaccine.
Immediate anaphylactic reaction after a previous dose.
Encephalopathy within 7 days of a previous pertussis-containing vaccine.
Not for use in individuals aged 7 years or older.
Warnings and Precautions
General: Do not administer intravascularly or intradermally. Protective immune response may not be elicited in all vaccinees.
Injection Precautions: Administer deep intramuscularly at a different site for each injection. Epinephrine should be available for immediate use in case of anaphylactic reactions.
Hematologic: Caution in subjects with thrombocytopenia or a bleeding disorder.
Immune Response: May be diminished in immunosuppressed individuals.
Neurologic: Defer pertussis vaccination in children with progressive neurological disorders until stabilized.
Adverse Reactions
Common: Loss of appetite, irritability, abnormal crying, restlessness, pain, redness, swelling at the injection site, fever >38°C, fatigue.
Uncommon: Upper respiratory tract infection, somnolence, cough, diffuse swelling of the injected limb.
Rare: Bronchitis, rash.
Very Rare: Convulsions, dermatitis, bronchospasm, urticaria.
Post-Marketing: Reports of Sudden Unexpected Death (SUD) in the first year of life, although a causal relationship has not been established.
Drug Interactions
Do not mix with any other vaccine in the same syringe or vial.
Can be given concomitantly with pneumococcal conjugate, MenC conjugate, MenACWY conjugate, rotavirus, MMR, and varicella vaccines at separate sites.
Immunosuppressive therapies may reduce the immune response.
Dosage and Administration
Primary Immunization:
3-dose schedule: At least 1 month apart, starting at 6 weeks of age.
2-dose schedule: At least 1 month apart, with a booster at 12 to 23 months.
Booster Dose: At least 6 months after the last priming dose, administered at 12 to 23 months.
Administration: Reconstitute by adding the entire contents of the syringe to the vial containing the Hib pellet. Administer intramuscularly in the anterolateral aspect of the thigh or deltoid muscle.
Storage and Stability
Store at 2°C to 8°C. Do not freeze. Protect from light. Use immediately after reconstitution, but stable for up to 8 hours at 21°C.
Clinical Trials and Efficacy
Immunogenicity: High immune response rates for all antigens after 3-dose and 2-dose primary vaccination schedules, with robust antibody responses observed in clinical studies.
Protective Efficacy: Demonstrated high efficacy in preventing pertussis, diphtheria, tetanus, hepatitis B, poliomyelitis, and Hib disease.
Persistence of Immune Response: Protective immunity against hepatitis B, poliovirus, and Hib persisted in children 4-8 years after vaccination.
