Indication: Booster vaccination against diphtheria, tetanus, and pertussis (whooping cough) for individuals aged 4 years and older.
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 or a severe allergic reaction to a previous dose of diphtheria, tetanus, or pertussis vaccines.
History of encephalopathy of unknown etiology occurring within 7 days following previous pertussis vaccination.
Individuals who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus.
Dosage and Administration
Dose: Single 0.5 mL intramuscular injection.
Recommended Intervals: Booster doses should be administered as per official recommendations (generally every 10 years). If given to pregnant women, ideally administered during the third trimester.
Administration: Deep muscular injection, preferably in the deltoid muscle.
Adverse Reactions
Common: Injection site pain, redness, swelling, fatigue, headache, malaise, fever, and gastrointestinal symptoms.
Less Common: Upper respiratory tract infections, syncope, dizziness, rash, pruritus, joint stiffness, and musculoskeletal pain.
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 and potential risks. Should not be administered intravenously.
Hematologic: Caution in individuals with thrombocytopenia or bleeding disorders.
Immune Response: May be suboptimal in immunocompromised individuals.
Neurologic: Defer vaccination in children with progressive neurological disorders until stabilized.
Pregnant Women: Safe based on studies; no vaccine-related adverse effects on pregnancy or the health of the fetus/newborn.
Breastfeeding: Safety not fully evaluated; use only when benefits outweigh potential risks.
Drug Interactions
Concomitant Administration: Can be administered with other vaccines or immunoglobulin at different sites. Immunosuppressive therapy may reduce immune response.
Interactions: No established interactions with food, herbs, or laboratory tests.
Storage and Stability
Storage: Store at 2°C to 8°C. Do not freeze. Stable for 8 hours at 21°C. Protect from light.
Clinical Trials and Efficacy
Immunogenicity: High seroprotection and seropositivity rates for diphtheria, tetanus, and pertussis antigens observed one month post-vaccination.
Persistence: Immunity persists up to 10 years after booster vaccination, with high rates of seroprotection and seropositivity.
Effectiveness: Demonstrated protective efficacy against pertussis, with maternal immunization providing passive protection to infants.
