An Extension Study to Determine the Persistence of Tick-borne Encephalitis (TBE)-Specific Antibody Responses Among Children and Adolescents Previously Immunized Against TBE

Novartis

Status and phase: Completed; Phase 4

Conditions: Tick Borne Encephalitis (TBE)

Treatments: Other: Serology blood draw

Study type: Interventional

Funder types: Industry

Identifiers

NCT01106482

M48P3E1

Details and patient eligibility

About

This study will evaluate the durability of antibody responses in children and adolescents after primary immunization with TBE vaccine

Enrollment: 126 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy study subjects from the parent study who completed the primary vaccination series, with parental or legal guardian informed consent

Exclusion criteria

• Subjects who did not receive complete schedule of primary vaccination in the parent study
• Subjects enrolled in other investigational studies at the same time and within the last three months
• Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 4 patient groups

Arm 1

Active Comparator group

Treatment:

Other: Serology blood draw

Arm 2

Active Comparator group

Treatment:

Other: Serology blood draw

Arm 3

Active Comparator group

Treatment:

Other: Serology blood draw

Arm 4

Active Comparator group

Treatment:

Other: Serology blood draw