Clinical trial NCT00161941: 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Meninigitis, Serogroup C
Keywords: Meningococcal Vaccine
Meningococcal Meningitis, Serogroup C
Neisseria Meningitidis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 321
Sex: ALL
Minimum age (years): 5
Maximum age (years): 22
Standard ages: CHILD
Accepts healthy volunteers: yes

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
city: Augsburg
country: Germany
facility: Neuschwansteinstrasse 5
city: Bad Saulgau
country: Germany
facility: Marktplatz 3
city: Bietigheim-Bissingen
country: Germany
facility: Hauptrasse 9
city: Ettenheim
country: Germany
facility: Rheinstrasse13
city: Heilbronn
country: Germany
facility: Solothurner Strasse 2
city: Kehl
country: Germany
facility: Hauptrasse 240
city: Nördlingen
country: Germany
facility: Löpsinger Strasse 8
city: Oberndorf / Neckar
country: Germany
facility: Tuchbergstrass 2
city: Roding
country: Germany
facility: Falkensteiner Str. 24
city: Schrammberg
country: Germany
facility: Berneckstrasse 19
Study officials:
affiliation: Private practice, Hauptstrasse, Kehl, Germany
name: Ulrich Behre, MD
role: PRINCIPAL_INVESTIGATOR
References: