BOOSTRIX®-POLIO

Product Information

• Name: BOOSTRIX®-POLIO
• Type: Combined diphtheria, tetanus, acellular pertussis (adsorbed), and inactivated poliomyelitis vaccine
• Form: Suspension for injection
• Manufacturer: GlaxoSmithKline Inc.

Indications and Clinical Use

• Indication: Booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis for individuals aged 4 years and older.
• Use in Pregnancy: Provides passive protection against pertussis in early infancy following maternal immunization during pregnancy.
• Not for Primary Immunization: Intended solely as a booster dose.

Contraindications

• Hypersensitivity to any component of the vaccine.
• Encephalopathy of unknown etiology occurring within 7 days following previous pertussis vaccination.
• History of transient thrombocytopenia or neurological complications following earlier immunization against diphtheria and/or tetanus.

Dosage and Administration

• Dose: Single 0.5 mL intramuscular injection.
• Recommended Intervals: Booster doses at intervals as per official recommendations (generally 10 years). Ideally administered during the third trimester of pregnancy.
• Administration: Intramuscular injection, preferably in the deltoid muscle. Do not administer intravenously, intradermally, or subcutaneously.

Adverse Reactions

• Common: Injection site pain, redness, swelling, fatigue, headache, fever, gastrointestinal symptoms, irritability.
• Less Common: Upper respiratory tract infections, sleep disorders, apathy, gastrointestinal disorders, and fatigue.
• Serious: Rare cases of anaphylaxis, extensive limb swelling, Guillain-Barré syndrome, and convulsions.

Warnings and Precautions

• General: Immunization should be preceded by a review of the individual's medical history.
• Injection Precautions: Avoid intravascular administration.
• Moderate or Severe Illness: Vaccination should be postponed.
• Neurological Disorders: Consider deferring pertussis immunization in children with progressive neurological disorders until stabilized.
• Pregnancy and Breastfeeding: Safe based on studies; no adverse effects on pregnancy or the health of the fetus/newborn. Use during lactation only when benefits outweigh risks.

Drug Interactions

• Concomitant Administration: Can be administered with other inactivated vaccines or immunoglobulin at different sites. Immunosuppressive therapy may reduce immune response.
• Interactions: No evidence of significant interactions with food, herbs, or laboratory tests.

Storage and Stability

• Storage: Store at 2°C to 8°C, do not freeze. Protect from light.

Clinical Trials and Efficacy

• Efficacy: High seroprotection rates and immune responses against diphtheria, tetanus, pertussis, and poliovirus observed in clinical trials.
• Safety in Children: Evaluated in clinical studies involving children aged 4 to 9 years, showing mild to moderate adverse reactions.
• Safety in Adults and Adolescents: Evaluated in clinical trials with individuals aged 10 years and older, demonstrating common mild to moderate adverse reactions.