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Tick-borne encephalitis vaccine

Phase 4

Tick-borne Encephalitis | Vaccine | Infectious Disease |Pfizer, Inc.|Trials Updated: Jan 19, 2024

Tick-borne encephalitis vaccine development status

Highest phase Phase 4 run by Novartis (NCT00311493)
Phase scored for PFEPhase 3
Registered trials 4 across 2 sponsors since Sep 2005

Tick-borne encephalitis vaccine target and mechanism

ModalityVaccine

Also known as Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials8
Total Enrollment9,305

FDA Designations

No designations recorded

Tick-borne encephalitis vaccine clinical trials

Tick-borne encephalitis vaccine · 8 trials · 2 indications

Phase 3 3Phase 2 5
NCT00840801Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in ChildrenEncephalitis, Tick-Borne
COMPLETED302 Analytics
NCT00161876FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 YearsEncephalitis, Tick-borne
COMPLETED3,973 Analytics
NCT00161824Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUREncephalitis, Tick-borne
COMPLETED3,800 Analytics
PHASE3COMPLETED
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Encephalitis, Tick-BorneUnlock trial analytics
PHASE3COMPLETED
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
Encephalitis, Tick-borneUnlock trial analytics
PHASE3COMPLETED
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
Encephalitis, Tick-borneUnlock trial analytics

Study Endpoints

Primary Endpoints

Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
28 days after Vaccination 2

Percentage of participants achieving NT titer greater than or equal to (\>=) 10.

Secondary Endpoints

Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
180 days after the Vaccination 1, 28 days after the Vaccination 3
Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALSubjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
2EXPERIMENTALSubjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

Interventions

NameTypeDescription
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)BIOLOGICALSubjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
Tick-borne Encephalitis VaccineBIOLOGICAL -
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Eligibility Criteria

Age Range1 Year to 11 Years
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: Male and female children will be eligible for participation in this study if: * they are aged \>= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening; * their parents / legal guardians provide written informed consent; * children ...

Countries:AustriaCzechiaPolandGermany
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Frequently asked questions about Tick-borne encephalitis vaccine

What is the tick-borne encephalitis vaccine used for?

The tick-borne encephalitis vaccine is used to prevent tick-borne encephalitis, a viral infection of the central nervous system transmitted by tick bites. It is an inactivated vaccine developed by Pfizer, Inc. (NYSE: PFE) and is given to healthy children and adults to protect against the disease.

Who makes the tick-borne encephalitis vaccine?

The tick-borne encephalitis vaccine is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company responsible for the vaccine's clinical development program, including the Phase 3 trials that have evaluated its immunogenicity and safety in children and adults.

What phase is the tick-borne encephalitis vaccine in?

The tick-borne encephalitis vaccine is in Phase 3 clinical development. It has completed eight clinical trials, including Phase 3 studies, and is not yet approved. The vaccine remains an investigational product undergoing evaluation for the prevention of tick-borne encephalitis.

What clinical trials is the tick-borne encephalitis vaccine in?

The tick-borne encephalitis vaccine has been studied in eight completed clinical trials, including NCT00840801, a Phase 3 immunogenicity and safety study in children; NCT00161876, a Phase 3 follow-up study in adults aged 16 to 66; and NCT00161889 and NCT00161850, Phase 2 follow-up studies in children.

Is the tick-borne encephalitis vaccine the same as TBE vaccine (inactivated)?

Yes, the tick-borne encephalitis vaccine is also known as Tick-Borne Encephalitis (TBE) Vaccine (Inactivated). The two names refer to the same inactivated vaccine developed by Pfizer, Inc. (PFE) for the prevention of tick-borne encephalitis.

How many people have been enrolled in tick-borne encephalitis vaccine trials?

Across eight completed clinical trials, 9,305 participants have been enrolled in studies of the tick-borne encephalitis vaccine. The trials were randomized, double-blind, and controlled, and included healthy volunteers ranging from children as young as 1 year to adults up to 66 years of age.