General Information

Ticovac (tick-borne encephalitis (TBE) vaccine) in designed to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

Ticovac is specifically indicated for active immunization to prevent tick-borne encephalitis (TBE). TICOVAC is approved for use in individuals 1 year of age and older.

Ticovac is supplied as a suspension for intramuscular injection. The Dosage and Vaccination Schedule is as follows:

• 1 through 15 years of age: each dose 0.25 mL
• 16 years of age and older: each dose 0.5 mL

Primary Vaccination: Three doses

Complete the primary immunization series at least 1 week prior to potential exposure to TBEV (tick-borne encephalitis virus).

A booster dose (fourth dose) may be given at least 3 years after completion of the primary immunization series if ongoing exposure or re-exposure to TBEV is expected.

Mechanism of Action

Ticovac (tick-borne encephalitis (TBE) vaccine) in designed to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature. Following administration, Ticovac induces TBEV-neutralizing antibodies, which are believed to confer protection. However, a protective antibody level has not been defined.

Side Effects

Adverse effects associated with the use of Ticovac may include, but are not limited to, the following:

• Individuals 1 through 15 years of age:
  • local tenderness
  • local pain
  • headache
  • fever
  • restlessness
• Individuals 16 through 65 years of age:
  • local tenderness
  • local pain
  • fatigue
  • headache
  • muscle pain

Clinical Trial Results

The FDA approval of Ticovac was based on clinical trials evaluating the safety and immunogenicity of Ticovac, which was assessed across two age groups (1-15 years of age and >16 years of age). In these studies, seropositivity rates were 99.5% in 1-15 year olds and 98.7-100% in adults >15 years following three doses.