Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

Novartis

Status and phase: Completed; Phase 4

Conditions: Tick Born Encephalitis

Treatments: Biological: TBE vaccine for adults

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387634

V48P7E1

Details and patient eligibility

About

evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

Enrollment: 323 patients

Sex: All

Ages: 15 to 68 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy subjects who have completed study V48P7

Exclusion criteria

• acute illness at day of immunization
• general decrease in resistance
• progressive neurological disorders
• history of febrile or afebrile convulsions
• major congenital defects
• serious chronic illness
• hypersensitivity to study vaccine
• treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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323 participants in 4 patient groups

Arm 1

Active Comparator group

Description:

Blood draw only, no vaccine

Treatment:

Biological: TBE vaccine for adults

Arm 2

Active Comparator group

Description:

Blood draw only, no vaccine

Treatment:

Biological: TBE vaccine for adults

Arm 3

Active Comparator group

Description:

Blood draw only, no vaccine

Treatment:

Biological: TBE vaccine for adults

Arm 4

Active Comparator group

Description:

Blood draw only, no vaccine

Treatment:

Biological: TBE vaccine for adults