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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161941 |
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 |
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Meningococcal Meninigitis, Serogroup C |
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 |
Ages Eligible for Study: | 5 Months to 22 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Study subjects who completed study 216 will be eligible for participation in this study if:
Exclusion Criteria:
Study subjects will be excluded from participation in this study if:
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 |
Principal Investigator: | Ulrich Behre, MD | Private practice, Hauptstrasse, Kehl, Germany |
Study ID Numbers: | 224 |
Study First Received: | September 8, 2005 |
Last Updated: | October 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00161941 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women; Germany: Paul-Ehrlich-Institut |
Meningococcal Vaccine Meningococcal Meningitis, Serogroup C Neisseria Meningitidis |
Liver Diseases Meningitis, Meningococcal Whooping Cough Hepatitis, Viral, Human Neisseria Meningitidis Healthy Meningitis |
Hepatitis Virus Diseases Antibodies Digestive System Diseases Hepatitis B DNA Virus Infections Immunoglobulins |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Hepadnaviridae Infections |