Vaccines:

Indications for: TICOVAC

Active immunization to prevent tick-borne encephalitis (TBE).

Clinical Trials:

Primary Immunization Course

The immunogenicity of TicoVac described in this section is based on results from the following studies:

  • Study 209 (ClinicalTrials.gov Identifier: NCT00161863): Healthy participants 1 through 15 years of age TBE seronegative at baseline received three vaccinations with TicoVac. The first two vaccinations were given 1 month apart followed by the third vaccination 6 months after the first vaccination.
  • Study 213 (ClinicalTrials.gov Identifier: NCT00161876): Healthy participants 16 to 64 years of age TBE seronegative at baseline who had received two vaccinations in Study 208 given one month apart, received a third vaccination with TicoVac 6 months after the first vaccination in Study 208.
  • Study 690601 (ClinicalTrials.gov Identifier: NCT00460486): Healthy participants 16 years of age and older TBE seronegative at baseline received three vaccinations with TicoVac. The first two vaccinations were given 14 days apart followed by the third vaccination 6 months after the first vaccination.

The neutralization test (NT) seropositivity rates 21 days after the third vaccination in participants 1 through 15 years of age vaccinated with TicoVac in Study 209 are the following:

  • 1–5 years:  99.2% (95% CI, 95.7–100.0)
  • 6–15 years:  99.6% (95% CI, 97.7–100.0)

The NT seropositivity rates 21 days after the third vaccination in participants 16 years of age and older vaccinated with TicoVac in Study 690601 and Study 213.

  • 16–64 years (Study 213):  98.8% (95% CI, 97.2–99.6)
  • 16–49 years (Study 690601):  100.0% (95% CI, 97.5–100.0)
  • ≥50 years (Study 690601):  98.7% (95% CI, 95.4–99.8)

Seven days after the third vaccination, 90.6% of the participants 16 years of age and older were seropositive (Study 690601).

Seropersistence and Booster Vaccination

Two open-label, multi-center, follow-up studies which enrolled participants who were seropositive 1 month after the third vaccination from Studies 213 (N=252, ages 16 through 65 at the time of first TicoVac dose) and 209 (N=358, ages 1 through 15 at the time of first TicoVac dose) were conducted to assess the seropersistence of TBE antibodies after completion of the primary vaccination series and the antibody response to a booster administration.

  • Three years after the primary series of TicoVac, NT seropositivity in follow-up studies 223 and 700401 ranged from 82.9% to 100% depending on age.
  • Following a booster dose, the NT seropositivity rates were 100%.

Adults and Children:

<1yr: not established. Give by IM inj only. Primary vaccination (3-dose series): 1–15yrs: each dose is 0.25mL; give 1st dose at elected date, 2nd dose 1–3mos after the 1st dose, and 3rd dose 5–12mos after the 2nd dose. ≥16yrs: each dose is 0.5mL; give 1st dose at elected date, 2nd dose 14days–3mos after the 1st dose, and 3rd dose 5–12mos after the 2nd dose. Complete primary series at least 1 week prior to exposure to TBE virus. Booster vaccination (4th dose): may be given at least 3yrs after primary series if ongoing or re-exposure.

TICOVAC Warnings/Precautions:

Immunocompromised. Have appropriate medical treatment and supervision readily available. Contains human albumin; potential risk for infection transmission (eg, viruses, Creutzfeldt-Jakob disease). Pregnancy. Nursing mothers.

Adverse Reactions:

Local tenderness/pain, headache, fever, restlessness, fatigue, muscle pain.

Generic Drug Availability:

NO

How Supplied:

Prefilled syringes (0.25mL, 0.5mL)—1, 10