Tetraxim

Approved Indications:

• Primary immunization of infants and children aged ≥6 weeks for prevention of:
• Diphtheria
• Tetanus
• Pertussis (Whooping Cough)
• Poliomyelitis (Types 1, 2, and 3)
• Booster immunization in:
• Children aged 4–6 years (DTaP-IPV)
• Adolescents aged 11–12 years (Tdap-IPV in some regions)
• Adults needing tetanus and pertussis protection along with IPV
• Maternal Immunization (Tdap component):
• One dose during each pregnancy (preferably 27–36 weeks gestation) to protect infants from pertussis
• Catch-up vaccination for:
• Individuals of any age who missed routine doses
• Children or adults with incomplete vaccination history

Route of Administration: Intramuscular (IM), preferably in the anterolateral thigh (infants) or deltoid (older children/adults)

Pediatric Dosing (DTaP-IPV):

• Primary series:
• 0.5 mL at 2, 4, and 6 months of age
• Booster doses:
• 0.5 mL at 15–18 months
• 0.5 mL at 4–6 years

Adolescent/Adult Dosing (Tdap-IPV):

• Single dose of Tdap-IPV at 11–12 years
• Additional booster of Td or Tdap every 10 years
• Pregnant women: One Tdap dose during each pregnancy

Catch-Up Schedule:

• Follows standard CDC/WHO guidance based on age and number of previous doses

Special Populations:

• Preterm infants: Follow same schedule; monitor for apnea
• Immunocompromised: May have reduced response but still recommended
• Wound prophylaxis: Tetanus-containing component (Tdap or Td) may be used as per wound management protocols

The DTaP-IPV / Tdap-IPV vaccine is a combination of inactivated bacterial toxins (toxoids) and viral antigens that stimulate humoral and cellular immune responses. Diphtheria and tetanus toxoids induce neutralizing antibodies against their respective exotoxins. The acellular pertussis components (e.g., pertussis toxin, filamentous hemagglutinin, pertactin) elicit protective immunity that reduces colonization and toxin-related disease. The IPV component contains inactivated poliovirus types 1, 2, and 3, which promote the formation of neutralizing antibodies that prevent viral replication and CNS involvement, thereby preventing paralytic poliomyelitis.

Vaccines do not follow traditional ADME pharmacokinetics, but:

• Absorption: Localized at the injection site; antigen uptake by dendritic cells
• Onset of Immunity: Begins ~2 weeks after the first dose; full protection requires complete vaccination
• Duration of Protection:
• Diphtheria/Tetanus: ~10 years
• Pertussis: ~4–6 years (waning immunity)
• IPV: Long-lasting; boosters required in high-risk settings
• Distribution: Antigens remain localized before being processed by the immune system
• Metabolism/Excretion: Biodegraded via normal protein pathways; not renally excreted

• Pregnancy:
• Tdap-IPV is safe and recommended during pregnancy (preferably 27–36 weeks gestation) to protect newborns from pertussis
• No known teratogenic effects
• Lactation:
• Safe to receive while breastfeeding
• No effect on milk production or composition
• Does not pose risk to the infant

• Primary Class: Inactivated Vaccine
• Subclass: Toxoid and viral antigen combination vaccine
• DTaP-IPV: Pediatric use (higher antigen content)
• Tdap-IPV: Adolescent/adult use (reduced diphtheria and pertussis antigens)

• Known hypersensitivity to any vaccine component (e.g., formaldehyde, neomycin, polymyxin B, latex if applicable)
• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of DTP, DTaP, Tdap, IPV, or related vaccines
• History of encephalopathy within 7 days after a pertussis-containing vaccine
• Progressive or unstable neurological disorder (defer until stabilized)

• Preterm infants: Monitor for apnea post-vaccination
• Seizure history: Use with caution; consider prophylactic antipyretics
• Guillain-Barré Syndrome (GBS): Rare; weigh risks and benefits in patients with previous GBS after tetanus vaccine
• Syncope: Observe adolescents for 15 minutes after injection to prevent fall injury
• Fever ≥40°C, persistent crying >3 hrs, or hypotonic episodes after previous dose may require caution before re-administration

Common (≥10%):

• Local: Pain, redness, or swelling at injection site
• Systemic: Fever, irritability, fatigue, loss of appetite

Less Common (1–10%):

• Vomiting
• Diarrhea
• Drowsiness
• Headache (in adolescents)

Rare/Serious (<0.1%):

• Hypotonic-hyporesponsive episode (HHE)
• Febrile or afebrile seizures
• Anaphylaxis
• Brachial neuritis
• Guillain-Barré Syndrome (GBS)

Time of Onset: Usually within 24–72 hours; serious events typically occur within 7 days

• Live vaccines: Can be co-administered at different sites using separate syringes
• Immunosuppressive therapies: May reduce immune response; avoid routine vaccines during active immunosuppression if possible
• Antipyretics (e.g., paracetamol): Can reduce fever but may slightly lower immune response
• No CYP450 metabolism involvement or drug-food-alcohol interactions

• WHO & CDC: Reinforced the need for adolescent and adult Tdap boosters to prevent pertussis resurgence
• Pregnancy immunization: Tdap during every pregnancy now standard for passive infant protection
• Eradication efforts: IPV now essential globally as part of the poliovirus eradication initiative; OPV phased out in most countries

• Temperature: Store at 2°C to 8°C (36°F to 46°F)
• Do Not Freeze: Freezing destroys vaccine potency
• Light Protection: Keep in original packaging
• Handling: Shake well before use; do not use if discolored or containing particles
• Shelf Life: Use before the expiration date printed on the vial or prefilled syringe