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Follow-up Study on the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens 1 Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in NeisVac-C Study 216
This study has been completed.
Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00161941
  Purpose

The primary aim of the study is to show that the antibody response to hepatitis B, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac® is not influenced by the concomitant administration of NeisVac-C.


Condition
Meningococcal Meninigitis, Serogroup C

MedlinePlus related topics: Hepatitis Hepatitis B Whooping Cough
Drug Information available for: Hepatitis B Vaccines Immunoglobulins Globulin, Immune Meningococcal Vaccines
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title: Open-Label Multicenter Phase 3B Follow-up Study to Investigate the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens One Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in the NeisVac-C Non-Interference Study 216

Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 321
Study Start Date: June 2003
Estimated Study Completion Date: December 2003
  Eligibility

Ages Eligible for Study:   5 Months to 22 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Study subjects who completed study 216 will be eligible for participation in this study if:

  • they received all 3 vaccinations with Hexavac during study 216 and the 4th Hexavac vaccination outside the study
  • the subject’s parent(s)/legal guardian(s) understands the study and has provided written informed consent for his/her child’s study participation;
  • a blood draw was performed after the 3rd vaccination during study 216.

Exclusion Criteria:

Study subjects will be excluded from participation in this study if:

  • they have received any vaccination containing hepatitis B, poliovirus or acellular pertussis toxin antigens other than Hexavac
  • they have received a blood transfusion or immunoglobulins during the period from 28 days prior to the 4th Hexavac vaccination until study entry
  • they have received another vaccine during the period from 28 days prior to the 4th Hexavac vaccination until study entry
  • they are concurrently participating in or have participated in a clinical trial with an investigational medicinal product since the completion of study 216
  • they suffer from a disease (e.g. autoimmune disease) or were undergoing a form of treatment that may be expected to influence immunological functions since the completion of study 216
  • they have received systemic corticosteroids during the period from 28 days prior to the 4th Hexavac vaccination until study entry.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161941

Locations
Austria
Grieskirchner Strasse 17
Wels, Austria, 4600
Germany
Marktplatz 3
Bad Saulgau, Germany, 88348
Hauptrasse 9
Bietigheim-Bissingen, Germany, 74321
Solothurner Strasse 2
Heilbronn, Germany, 74072
Rheinstrasse13
Ettenheim, Germany, 77955
Falkensteiner Str. 24
Roding, Germany, 93426
Tuchbergstrass 2
Oberndorf / Neckar, Germany, 78727
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
Löpsinger Strasse 8
Nördlingen, Germany, 86720
Hauptrasse 240
Kehl, Germany, 77694
Berneckstrasse 19
Schrammberg, Germany, 78713
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Ulrich Behre, MD Private practice, Hauptstrasse, Kehl, Germany
  More Information

Study ID Numbers: 224
Study First Received: September 8, 2005
Last Updated: October 19, 2006
ClinicalTrials.gov Identifier: NCT00161941  
Health Authority: Austria: Federal Ministry for Health and Women;   Germany: Paul-Ehrlich-Institut

Keywords provided by Baxter Healthcare Corporation:
Meningococcal Vaccine
Meningococcal Meningitis, Serogroup C
Neisseria Meningitidis

Study placed in the following topic categories:
Liver Diseases
Meningitis, Meningococcal
Whooping Cough
Hepatitis, Viral, Human
Healthy
Neisseria meningitidis
Whooping cough
Meningitis
Hepatitis
Virus Diseases
Antibodies
Digestive System Diseases
Hepatitis B
DNA Virus Infections
Immunoglobulins

Additional relevant MeSH terms:
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009