Unveiling Typbar-TCV™: A Comprehensive Guide to Typhoid Fever Vaccination

In the realm of preventive healthcare, vaccines play a crucial role in safeguarding individuals against various diseases. Among them, Typbar-TCV™ stands out as a beacon in the fight against typhoid fever. This blog post aims to provide a comprehensive understanding of Typbar-TCV™, simplifying the medical information for a general audience without a medical background.

1. Name and Description of the Medicinal Product

Typbar-TCV™ is a clear to slightly turbid liquid containing purified Vi capsular polysaccharide of Salmonella typhi Ty2 conjugated to the carrier protein Tetanus Toxoid. It is a T-cell dependent vaccine, inducing Vi antibodies that neutralize Vi antigen. Suitable for infants aged ≥6 months to adults ≤45 years, it fulfills the WHO requirements for Typhoid Vi Conjugate vaccine.

2. Qualitative and Quantitative Composition

Single Dose (0.5 mL)

  • Purified Vi-Capsular Polysaccharide of S. typhi Ty2 conjugated to Tetanus Toxoid: 25 μg
  • Sodium chloride: 4.5 mg
  • Water for Injections (WFI): q.s. to 0.5 mL

Multi Dose (2.5 mL)

  • Purified Vi-Capsular Polysaccharide of S. typhi Ty2 conjugated to Tetanus Toxoid: 25 μg
  • Sodium chloride: 4.5 mg
  • 2-Phenoxyethanol (Preservative): 5 mg
  • Water for Injections (WFI): q.s. to 0.5 mL

3. Pharmaceutical Form

Suspension for Injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Typbar-TCV™ is indicated for active immunization against Salmonella typhi infection in the age group of ≥6 months to ≤45 years.

4.2 Posology and Method of Administration

  • Dosage: Inject 0.5 mL intramuscularly.
  • Administration Site: Intramuscular injection in the deltoid or the vastus lateralis. Avoid injection into the gluteal area or areas with nerve trunks.
  • Prevention Effectiveness: Becomes effective in 2-3 weeks after immunization.

4.3 Dosage & Schedule

  • The immunizing dose for adults, children, and infants of age ≥6 months to ≤ 45 years is a single dose of 0.5 mL.
  • A booster dose may be given after 3 years.

4.4 Contraindications

  • Hypersensitivity: Avoid if allergic to any constituent of the vaccine.
  • Pregnant & Lactating Women: Not recommended.
  • Fever or Severe Infection: Postpone vaccination.

4.5 Special Warning / Precautions

  • Administration: Do not administer intravenously, intradermally, or subcutaneously.
  • Protection Scope: Protects against typhoid fever caused by Salmonella typhi Ty2, not against other Salmonellae.
  • Anaphylactic Reaction: Epinephrine (1:1000) must be available immediately for acute reactions. Medical supervision for at least 30 minutes after vaccination is essential.

4.6 Interaction with Other Medicinal Products/ Other Forms of Interaction

  • For concomitant use, different injection sites and separate syringes are recommended.
  • Avoid mixing Typbar-TCV™ with any other vaccine or medicinal product.

4.7 Pregnancy and Lactation

  • Safety and effectiveness not established in pregnant women and nursing mothers.

4.8 Effect on Ability to Drive and Use Machines

  • No studies on the effect of Typbar-TCV™ on driving or machine usage have been conducted.

4.9 Adverse Reactions

Clinical Trial Experience

  • Phase II and III Trials: Established safety.
  • Adverse Events: Generally mild and temporary.
    • Common: Pain, swelling at injection site, fever, headache.
    • Uncommon: Tenderness, erythema at injection site, arthralgia, malaise, myalgia.
  • No Significant Vaccine-Related Serious Adverse Events.

5. Vaccine Vial Monitor

  • A time-temperature sensitive dot indicating cumulative heat exposure.
  • Alerts end-users if heat exposure has potentially degraded the vaccine beyond acceptable levels.

Conclusion

In the pursuit of global health, vaccines like Typbar-TCV™ play a pivotal role in preventing and controlling diseases. From its composition to administration and clinical particulars, this guide aims to provide a clear and simplified understanding of Typbar-TCV™ for individuals seeking to protect themselves against typhoid fever. As with any medical decision, consultation with healthcare professionals remains crucial for personalized advice and a well-informed choice.