Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

Novartis

Status and phase: Completed; Phase 4

Conditions: Encephalitis, Tick-Borne

Treatments: Procedure: blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT00452621

V48P4E3

Details and patient eligibility

About

blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children

Enrollment: 235 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)