Name: INFANRIX®-IPV/Hib (combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, Haemophilus influenzae type b vaccine)
Manufacturer: GlaxoSmithKline Inc.
Form: Sterile suspension for injection
Indications and Clinical Use
Primary Immunization: For infants from 6 weeks of age for active primary immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b (Hib).
Booster Vaccination: Administered at 18 months for children previously immunized with the primary series.
Contraindications
Hypersensitivity to any component of the vaccine.
Immediate anaphylactic reaction after a previous dose.
Encephalopathy of unknown etiology within 7 days of pertussis vaccination.
Not for use in individuals 5 years of age or older.
Warnings and Precautions
General: Should not be administered intravenously. Monitor for allergic reactions post-vaccination. Postpone vaccination in cases of moderate or severe illness.
Hematologic: Caution in individuals with thrombocytopenia or bleeding disorders.
Immune Response: May be suboptimal in immunosuppressed individuals. Not contraindicated for HIV-infected persons.
Neurologic: Defer pertussis vaccination in children with progressive neurological disorders until stabilized.
Respiratory: Consider the risk of apnea in very premature infants following vaccination.
Adverse Reactions
Very Common (≥10%): Loss of appetite, irritability, abnormal crying, restlessness, pain and redness at injection site, fever >38°C, sleepiness.
Common (≥1% and <10%): Vomiting, diarrhea, injection site swelling, hard lump at injection site.
Uncommon (≥0.1% and <1%): Upper respiratory tract infection, swollen glands, cough, bronchitis, runny nose, rash, hives, high fever, fatigue.
Rare (≥0.01% and <0.1%): Itching and skin rash.
Very Rare (<0.01%): Bleeding or bruising easily, apnea in premature infants, swelling of the face, lips, or throat, blisters at injection site.
Drug Interactions
Can be administered with hepatitis B vaccine and measles-mumps-rubella (MMR) vaccine at different sites.
Not recommended for children on anticoagulant therapy unless benefits outweigh risks.
Dosage and Administration
Primary Immunization: 3 doses of 0.5 mL each at 2, 4, and 6 months of age.
Booster Immunization: One dose of 0.5 mL at 18 months.
Administration: Intramuscular injection, preferably in the anterolateral aspect of the thigh for infants.
Storage and Stability
Store at 2°C to 8°C, do not freeze. Use immediately after reconstitution. Stable for 8 hours at +21°C after reconstitution.
Clinical Trials and Efficacy
Immune Response: Over 99% of infants had protective antibody levels for diphtheria, tetanus, and poliovirus after the primary series. High seroprotection rates for Hib and pertussis antigens were also observed.
Protective Efficacy: Demonstrated high efficacy in preventing pertussis in clinical trials in Germany and Italy.
