What are the indications and administration guidelines for Tetraxim (Diphtheria, Tetanus, and Pertussis vaccine)?

Tetraxim: Indications and Administration Guidelines

Primary Indication

Tetraxim (DTaP-IPV) is indicated as a school-entry booster vaccination for children aged 4-7 years (specifically at 5 years of age in many programs) to maintain protection against diphtheria, tetanus, pertussis, and polio following waning immunity from infant/toddler primary series vaccination. 1, 2

Key Administration Guidelines

Age and Timing

• Administer at school entry (ages 4-7 years), typically at 5 years of age 1, 2
• This booster closes the immunity gap between waning protection from infant/toddler vaccination and future adolescent boosters 2
• The vaccine is specifically designed for this age group and should not be confused with Tdap (reduced antigen formulation) used in adolescents and adults 3, 4

Dosing

• Full 0.5 mL dose should be administered intramuscularly 3
• Do not use reduced doses, as this compromises immune response, particularly to pertussis antigens 5

Primary Vaccination Series Requirements

• Children must have completed their primary infant vaccination series (typically 3-4 doses) before receiving Tetraxim as a booster 3, 2
• If the fourth dose of the primary series was given on or after the fourth birthday, this school-entry booster may not be necessary 3

Safety Profile

Common Adverse Events

• Most common reactions are injection site erythema and swelling, typically occurring within 1 day (median) of vaccination 1
• The overall adverse event reporting rate is low at 8.8 subjects per 100,000 doses 1
• Serious adverse events are rare (13.6% of reported cases), primarily involving extensive limb swelling that may be misdiagnosed as cellulitis but represents extensive limb swelling (ELS) 1

Contraindications

• History of neurologic or severe hypersensitivity reaction (including anaphylaxis) to a previous dose 3
• History of Arthus-type hypersensitivity reaction or temperature >103°F (39.4°C) following prior tetanus toxoid 3

Common Misconceptions About Contraindications

The following are NOT contraindications to DTaP vaccination 3:

• Mild local reactions (soreness, redness, swelling) or fever <105°F (40.5°C)
• Mild acute illness with low-grade fever
• Current antimicrobial therapy
• Recent exposure to infectious disease
• Prematurity (use chronological age from birth and full doses)
• Family history of allergies, convulsions, SIDS, or adverse vaccine events

Clinical Effectiveness

• School-entry booster vaccination is particularly effective against increased pertussis incidence around school entry and reduces transmission to vulnerable infants 2
• Each vaccine antigen demonstrates high immunogenicity with satisfactory safety profile based on over 20 years of clinical and post-marketing data 2

Special Populations

Premature Infants

• Administer full 0.5 mL doses at the usual chronological age from birth 3
• Do not delay or reduce dosing based on prematurity 3

Children with Contraindications to Pertussis Component

• If pertussis vaccine is contraindicated, use DT (diphtheria-tetanus) instead of DTaP formulations 3
• Complete the same schedule with DT substituted for DTaP 3