Ticovac

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ticovac Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tick-borne encephalitis vaccine; 2.4mcg TBE inactivated virus; per 0.5mL; susp for IM inj; aluminum adsorbed; preservative-free.

    How Supplied

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

    Storage

    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.

    Manufacturer

    Pfizer Inc.

    Generic Availability

    NO

    Mechanism of Action

    Ticovac induces TBEV-neutralizing antibodies, which are believed to confer protection.

    Ticovac Indications

    Indications

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

    Ticovac Dosage and Administration

    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 Contraindications

    Not Applicable

    Ticovac Boxed Warnings

    Not Applicable

    Ticovac Warnings/Precautions

    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.

    Warnings/Precautions

    Human Albumin

    • 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.

    Pregnancy Considerations

    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. 

    Pediatric Considerations

    Safety and effectiveness of TicoVac have not been established in infants <1 year of age.

    Geriatric Considerations

    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 Pharmacokinetics

    See Literature

    Ticovac Interactions

    Not Applicable

    Ticovac Adverse Reactions

    Adverse Reactions

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

    Ticovac Clinical Trials

    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 Note

    Not Applicable

    Ticovac Patient Counseling

    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.

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