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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

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.
 
ClinicalTrials.gov Identifier: NCT00161941
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : May 21, 2015
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease
Meningococcal Meninigitis, Serogroup C

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Study Type : Observational
Enrollment : 321 participants
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
Study Start Date : June 2003
Study Completion Date : December 2003






Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 22 Months   (Child)
Sexes Eligible for Study:   All
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.

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): NCT00161941


Locations
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Austria
Grieskirchner Strasse 17
Wels, Austria, 4600
Germany
Neuschwansteinstrasse 5
Augsburg, Germany, 86163
Marktplatz 3
Bad Saulgau, Germany, 88348
Hauptrasse 9
Bietigheim-Bissingen, Germany, 74321
Rheinstrasse13
Ettenheim, Germany, 77955
Solothurner Strasse 2
Heilbronn, Germany, 74072
Hauptrasse 240
Kehl, Germany, 77694
Löpsinger Strasse 8
Nördlingen, Germany, 86720
Tuchbergstrass 2
Oberndorf / Neckar, Germany, 78727
Falkensteiner Str. 24
Roding, Germany, 93426
Berneckstrasse 19
Schrammberg, Germany, 78713
Sponsors and Collaborators
Pfizer
Investigators
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Principal Investigator: Ulrich Behre, MD Private practice, Hauptstrasse, Kehl, Germany
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ClinicalTrials.gov Identifier: NCT00161941    
Other Study ID Numbers: 224
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Keywords provided by Pfizer:
Meningococcal Vaccine
Meningococcal Meningitis, Serogroup C
Neisseria Meningitidis
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human