Type: Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Form: Suspension for injection
Manufacturer: Sanofi Pasteur Limited
Indications and Clinical Use
Indication: Active booster immunization for the prevention of tetanus, diphtheria, pertussis (whooping cough), and poliomyelitis in individuals aged 4 years and above.
Use: Recommended for booster vaccination during pregnancy for passive immunization against pertussis in young infants. Can be used as an alternative for the fifth dose of diphtheria, tetanus, acellular pertussis, and inactivated poliomyelitis vaccine (DTaP-IPV) in children aged 4 to 6 years.
Contraindications
Known systemic hypersensitivity reaction to any component of ADACEL®-POLIO.
Acute neurological disorders, such as encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine.
Warnings and Precautions
General: Health-care providers should inform recipients or guardians about the benefits and risks of immunization.
Injection Precautions: Should not be administered intravenously, intradermally, or subcutaneously. Avoid injection into the buttocks.
Febrile and Acute Disease: Vaccination should be postponed in cases of acute or febrile disease.
Hematologic: Use caution in individuals with bleeding disorders.
Immune Response: May be diminished in immunocompromised individuals.
Neurologic: Avoid in individuals with progressive neurological disorders or uncontrolled epilepsy until stabilized.
Adverse Reactions
Common: Pain at the injection site, swelling, redness, fever, headache, tiredness, body ache, and gastrointestinal symptoms such as nausea and diarrhea.
Severe: Rare cases of anaphylaxis, Guillain-Barré syndrome, and extensive limb swelling.
Drug Interactions
Concomitant Administration: Can be administered with hepatitis B vaccine and trivalent influenza vaccine using separate injection sites and syringes.
Dosage and Administration
Dose: Single 0.5 mL intramuscular injection. The preferred site is the deltoid muscle.
Fractional Doses: Not recommended. Effectiveness of fractional doses has not been determined.
Storage and Stability
Storage: Store at 2° to 8°C, do not freeze. Stable at up to 25°C for a maximum of 3 days (72 hours).
Clinical Trials and Efficacy
Safety in Children: Evaluated in clinical studies involving children aged 3 to 7 years and 4 to 6 years. Common reactions were mild to moderate, with pain at the injection site being the most frequent.
Safety in Adolescents and Adults: Evaluated in clinical trials with individuals aged 12 to 60 years. Most common reactions included pain at the injection site and systemic reactions such as headache and tiredness.
Immunogenicity: Demonstrated strong immune responses against diphtheria, tetanus, pertussis, and poliovirus with high percentages of participants achieving protective antibody levels.
