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

Primary Purpose

Encephalitis, Tick-Borne

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
blood draw
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Encephalitis, Tick-Borne focused on measuring blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children, TBE

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center 7
  • Center 2
  • Center 11
  • Center 4
  • Center 15
  • Center 1
  • Center 8
  • Center 16

Outcomes

Primary Outcome Measures

1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage

Secondary Outcome Measures

(2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce

Full Information

First Posted
March 26, 2007
Last Updated
April 22, 2008
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00452621
Brief Title
Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years
Official Title
A Phase IV, Uncontrolled, Open-Label, Multi-Center Study in Children and Adolescents: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New Pediatric TBE Vaccine (Free of Protein-Derived Stabilizer) in Study V48P4E1, Five Years After First Booster Immunization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Tick-Borne
Keywords
blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children, TBE

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
235 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
blood draw
Primary Outcome Measure Information:
Title
1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage
Secondary Outcome Measure Information:
Title
(2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Center 7
City
Aschaffenburg
ZIP/Postal Code
63741
Country
Germany
Facility Name
Center 2
City
Bobingen
ZIP/Postal Code
86399
Country
Germany
Facility Name
Center 11
City
Eberbach /Neckar
ZIP/Postal Code
69412
Country
Germany
Facility Name
Center 4
City
Kaufering
ZIP/Postal Code
86916
Country
Germany
Facility Name
Center 15
City
Pegnitz
ZIP/Postal Code
91257
Country
Germany
Facility Name
Center 1
City
Weilheim i. OB
ZIP/Postal Code
82362
Country
Germany
Facility Name
Center 8
City
Wiesloch
ZIP/Postal Code
69168
Country
Germany
Facility Name
Center 16
City
Zirndorf
ZIP/Postal Code
90513
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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