Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)

Product Specifications

Specification	Details
Manufacturer / Brand	Sanofi Vaccines US Inc. / Adacel®
Manufacturer # / SKU	49281040010
NDC Number	49281-0400-10
Vaccine Type	Tdap (Tetanus, Diphtheria, Acellular Pertussis)
Dose Volume	0.5 mL per Dose
Container Type	Single-Dose Vial (SDV)
Formulation	Preservative-Free, Sterile Suspension
Route of Admin	Intramuscular (IM) ONLY
Packaging	10 Vials per Carton
Storage	Refrigerate at 2°C to 8°C (36°F to 46°F); Do Not Freeze

Key Features

• Preservative-Free: Formulated without thimerosal or other preservatives, addressing patient preferences and reducing the risk of preservative-related sensitivities.

• Triple Protection: Provides comprehensive booster immunity in a single 0.5 mL injection, simplifying the immunization schedule for adolescents and adults.

• Highly Purified: Utilizes acellular pertussis components (PT, FHA, pertactin, and fimbriae types 2 and 3), which are associated with fewer local reactions compared to older whole-cell vaccines.

• Standard-of-Care: Widely recommended by the CDC/ACIP for adolescents (age 11-12) and adults who have not previously received a Tdap dose.

• Latex-Free Components: The vial stopper is not made with natural rubber latex, ensuring safety for patients with latex allergies.

Clinical Applications

• Adolescent Boosters: Standard 6th-grade/middle school entry requirement to boost immunity from childhood DTaP series.

• Adult Immunization: Used for adults requiring a tetanus booster if their last Tdap status is unknown or if they are in contact with infants.

• Pregnancy: Often administered during each pregnancy (ideally between 27 and 36 weeks) to provide passive immunity to the newborn.

• Wound Management: Used for tetanus prophylaxis in wound management for patients who have not received a tetanus-containing vaccine within the last 5 to 10 years.

⚠️ Usage Note: Shake the vial well before withdrawing the dose. The vaccine should appear as a uniform, white, cloudy suspension. Do not use if the product cannot be resuspended by shaking.

⚠️ Safety Alert: Syncope (fainting) can occur following vaccination. Patients should be seated or lying down during administration and observed for 15 minutes afterward.

⚠️ Contraindications: Do not administer to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or a history of encephalopathy within 7 days of a previous pertussis-containing vaccine.