Type: Combined diphtheria and tetanus toxoids, acellular pertussis vaccine adsorbed, inactivated poliomyelitis vaccine, and Haemophilus influenzae type b conjugate vaccine (tetanus protein-conjugate)
Form: Suspension for injection
Manufacturer: Sanofi Pasteur Limited
Indications and Clinical Use
Primary Immunization: For infants from the age of 2 months and children up to 6 years of age (before their 7th birthday) against diphtheria, tetanus, pertussis (whooping cough), poliomyelitis, and invasive Haemophilus influenzae type b (Hib) disease.
Not Indicated For: Persons less than 2 months or 7 years and older.
Contraindications
Hypersensitivity: Known systemic hypersensitivity to any component of the vaccine or life-threatening reaction after previous administration.
Neurological Disorders: Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause, progressive neurological disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy.
Warnings and Precautions
General: Health-care providers should inform the parent/guardian about benefits and risks, inquire about recent health status, and review immunization history and possible hypersensitivity.
Injection Site: Do not administer intravascularly or intradermally. Intramuscular injection preferred.
Acute Illness: Vaccination should be postponed in cases of acute or febrile disease.
Hematologic: Caution in persons with bleeding disorders or on anticoagulant therapy.
Immune Response: May be suboptimal in immunosuppressed individuals.
Neurologic: Monitor individuals with a history of convulsions; antipyretic administration may be necessary to reduce post-vaccination fever.
Adverse Reactions
Common: Injection site reactions (redness, swelling, tenderness), fever, irritability, abnormal crying, sleepiness, loss of appetite.
Severe: Rare cases of anaphylaxis, extensive limb swelling, convulsions, hypotonic-hyporesponsive episodes (HHE), high fever.
Drug Interactions
Concomitant Vaccines: Can be administered with other vaccines using separate syringes and sites.
Immunosuppressive Treatments: May interfere with the immune response.
Dosage and Administration
Primary Immunization Schedule:
4 doses of 0.5 mL at 2, 4, 6, and 18 months of age.
Administer intramuscularly, preferably in the anterolateral aspect of the thigh for infants and the deltoid muscle for older children.
Booster Doses: Booster with a vaccine containing diphtheria, tetanus, acellular pertussis, with or without IPV is required at 4 to 6 years of age.
Administration: Shake well before use, inspect for particulate matter, and do not use if discolored.
Storage and Stability
Storage: Store at 2° to 8°C, do not freeze. Protect from light. Stable at temperatures above 8°C and up to 25°C for a maximum of 3 days.
Clinical Trials and Efficacy
Efficacy: High efficacy in preventing diphtheria, tetanus, pertussis, poliomyelitis, and Hib disease, demonstrated in multiple clinical trials.
Immunogenicity: High seroprotection rates for all vaccine antigens after the primary series and booster doses.
Safety: Generally well-tolerated with mild to moderate adverse reactions. Severe reactions are rare.
