Trial record 15 of 32 for:    "Encephalitis, Tick-Borne"

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
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 April 17, 2014