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

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00452621
First received: March 26, 2007
Last updated: April 22, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Encephalitis, Tick-Borne
Procedure: blood draw
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Estimated Enrollment: 235
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452621

Locations
Germany
Center 7
Aschaffenburg, Germany, 63741
Center 2
Bobingen, Germany, 86399
Center 11
Eberbach /Neckar, Germany, 69412
Center 4
Kaufering, Germany, 86916
Center 15
Pegnitz, Germany, 91257
Center 1
Weilheim i. OB, Germany, 82362
Center 8
Wiesloch, Germany, 69168
Center 16
Zirndorf, Germany, 90513
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00452621     History of Changes
Other Study ID Numbers: V48P4E3
Study First Received: March 26, 2007
Last Updated: April 22, 2008
Health Authority: Germany:Paul-Ehrlich-Institute

Keywords provided by Novartis:
blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children
TBE

Additional relevant MeSH terms:
Encephalitis, Tick-Borne
Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Tick-Borne Diseases
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 01, 2014