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

May 20, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment

321

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wels, Austria, 4600
        • Grieskirchner Strasse 17
  • Germany
      • Augsburg, Germany, 86163
        • Neuschwansteinstrasse 5
      • Bad Saulgau, Germany, 88348
        • Marktplatz 3
      • Bietigheim-Bissingen, Germany, 74321
        • Hauptrasse 9
      • Ettenheim, Germany, 77955
        • Rheinstrasse13
      • Heilbronn, Germany, 74072
        • Solothurner Strasse 2
      • Kehl, Germany, 77694
        • Hauptrasse 240
      • Nördlingen, Germany, 86720
        • Löpsinger Strasse 8
      • Oberndorf / Neckar, Germany, 78727
        • Tuchbergstrass 2
      • Roding, Germany, 93426
        • Falkensteiner Str. 24
      • Schrammberg, Germany, 78713
        • Berneckstrasse 19

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Principal Investigator: Ulrich Behre, MD, Private practice, Hauptstrasse, Kehl, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion

December 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224 (registration study)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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