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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:
ClinicalTrials.gov Identifier:
NCT00452621
First Posted: March 27, 2007
Last Update Posted: April 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
  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
Intervention Model: Single Group Assignment
Masking: None (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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00452621     History of Changes
Other Study ID Numbers: V48P4E3
First Submitted: March 26, 2007
First Posted: March 27, 2007
Last Update Posted: April 23, 2008
Last Verified: April 2008

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
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Tick-Borne Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs