Ticovac Generic Name & Formulations
Store refrigerated at 2º C to 8º C (36º F to 46º F).
Keep the syringe in the outer carton in order to protect from light. Do not freeze. Discard if the vaccine has been frozen.
Mechanism of Action
Ticovac Dosage and Administration
Adults and Children
Ticovac Boxed Warnings
- TicoVac contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
Limitation of Vaccine Effectiveness
- Vaccination with TicoVac may not protect all individuals.
There are no adequate and well-controlled studies of TicoVac in pregnant women. Available human data are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy.
Nursing Mother Considerations
Human data are not available to assess the impact of TicoVac on milk production, its presence in breast milk, or its effects on the breastfed.
Consider the health benefits of breastfeeding along with the mother's clinical need for TicoVac and any potential adverse effects on the breastfed child from TicoVac or from the underlying maternal condition.
Safety and effectiveness of TicoVac have not been established in infants <1 year of age.
Clinical studies of TicoVac did not include sufficient numbers of participants aged 65 and over to determine whether they respond differently from younger participants.
Ticovac Adverse Reactions
Ticovac 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%.
Ticovac Patient Counseling
Inform the vaccine recipient the importance of completing the approved three dose primary immunization series before potential exposure to TBEV.
Report any suspected adverse reactions to a healthcare provider.