tick-borne encephalitis vaccine

Trade name: TICOVAC

Vaccineapproved

Approved

Aug 13, 2021

Tick-borne encephalitis vaccine is a vaccine used to prevent tick-borne encephalitis (TBE). The disease is most common in Central and Eastern Europe, and Northern Asia. More than 87% of people who receive the vaccine develop immunity. It is not useful following the bite of an infected tick. It is given by injection into a muscle. — Wikipedia

Clinical trial activity

34 trials · 27 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
14
Phase 3
9
Phase 4
17

Earliest trial started Apr 1, 1998 (NCT00161746)

Timeline

1990s

  1. Jan 1, 1998

    Pfizer — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Pfizer — Earliest Phase 3 Sponsor(trial)

2020s

  1. Aug 13, 2021

    Pfizer — Earliest FDA Approval

  2. Aug 13, 2021

    Pfizer — NDA Secondary Org

  3. Aug 13, 2021

    Pfizer — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedAug 13, 2021

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • fsme-immun
  • fsme immun cc
  • tbe vaccine
  • tick-borne encephalitis vaccine
  • tick-borne encephalitis virus
  • ticovac

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04573205Phase 4Jan 31, 2021Orebro University
NCT04648241Phase 3Jan 18, 2021Pfizer
NCT03294135Phase 4Oct 5, 2017GlaxoSmithKline
NCT04017052Phase 4Apr 15, 2015Medical University of Vienna
NCT02318069Phase 2/Phase 3 (Phase 3)Jan 1, 2015Helsingfors university, Karolinska Institute, Sormland County Council, Sweden
NCT01991067Phase 2Jul 1, 2014Austrian Science Fund (FWF), University of Vienna
NCT02511535Phase 4Sep 1, 2013University of Vienna
NCT02511587Phase 4Oct 1, 2012Medical University of Vienna, University of Vienna
NCT01710189Phase 4Oct 1, 2012University of London
NCT01582698Phase 4Apr 1, 2012Baxalta
NCT01361776Phase 2/Phase 3 (Phase 3)Sep 1, 2011Karolinska Institute, Sormland County Council, Sweden
NCT01131910Phase 2May 1, 2010Karolinska Institute, Sormland County Council, Sweden
NCT01031537Phase 2Sep 25, 2009National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
NCT00894686Phase 4Apr 1, 2009Baxalta, Pfizer
NCT00840801Phase 3Feb 1, 2009Baxalta, Pfizer
NCT00804219Phase 4Dec 1, 2008Medical University of Vienna, University of Vienna
NCT00644059Phase 3Nov 1, 2007Novartis
NCT00503529Phase 4Jul 1, 2007John Paul II Hospital, Krakow, Pfizer
NCT00461695Phase 4May 1, 2007University of Zurich
NCT00890422Phase 2Mar 1, 2007ASOKLIF, Baxalta, KH Elisabethinen Linz
Showing 20 of 34 trials
Page 1 / 2

Organizations

Research & Development (27)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit151531998
BaxaltaFor profit10131998
NovartisFor profit4422005
University of ViennaAcademic/Hospital4422008
Karolinska InstituteAcademic/Hospital3022010
Medical University of ViennaAcademic/Hospital3112008
Sormland County Council, SwedenGovernment3322010
Szpital Jana Pawla II Oddzial NeuoinfekcjiAcademic/Hospital3022001
Atopia Diagnostyka i Leczenie Chorob Alergicznych i Ukladu OddechowegoAcademic/Hospital2012001
Pantamed sp. z o o.Academic/Hospital2012001
Przedsiebiorstwo Uslug Medycznych Centrum Medyczne Nowa HutaAcademic/Hospital2012001
Samodzielny Publiczny SzpitalAcademic/Hospital2012001
Wojewodzki SzpitalAcademic/Hospital2012001
Zespol Opieki Zdrowotnej w DebicyAcademic/Hospital2012001
ASOKLIFAcademic/Hospital1012007
Austrian Science Fund (FWF)Government1012014
ChironFor profit1012006
GlaxoSmithKlineFor profit1112017
Helsingfors universityAcademic/Hospital1012015
John Paul II Hospital, KrakowAcademic/Hospital1012007
27 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
PfizerFor profitNDA2Aug 13, 2021
PfizerFor profitNDAAug 13, 2021