search
Back to results

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

Primary Purpose

Meningococcal Meninigitis, Serogroup C

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Meningococcal Meninigitis, Serogroup C focused on measuring Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis

Eligibility Criteria

5 Months - 22 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Grieskirchner Strasse 17
  • Neuschwansteinstrasse 5
  • Marktplatz 3
  • Hauptrasse 9
  • Rheinstrasse13
  • Solothurner Strasse 2
  • Hauptrasse 240
  • Löpsinger Strasse 8
  • Tuchbergstrass 2
  • Falkensteiner Str. 24
  • Berneckstrasse 19

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00161941
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meninigitis, Serogroup C
Keywords
Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis

7. Study Design

Enrollment
321 (false)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
22 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Behre, MD
Organizational Affiliation
Private practice, Hauptstrasse, Kehl, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grieskirchner Strasse 17
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Neuschwansteinstrasse 5
City
Augsburg
ZIP/Postal Code
86163
Country
Germany
Facility Name
Marktplatz 3
City
Bad Saulgau
ZIP/Postal Code
88348
Country
Germany
Facility Name
Hauptrasse 9
City
Bietigheim-Bissingen
ZIP/Postal Code
74321
Country
Germany
Facility Name
Rheinstrasse13
City
Ettenheim
ZIP/Postal Code
77955
Country
Germany
Facility Name
Solothurner Strasse 2
City
Heilbronn
ZIP/Postal Code
74072
Country
Germany
Facility Name
Hauptrasse 240
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Löpsinger Strasse 8
City
Nördlingen
ZIP/Postal Code
86720
Country
Germany
Facility Name
Tuchbergstrass 2
City
Oberndorf / Neckar
ZIP/Postal Code
78727
Country
Germany
Facility Name
Falkensteiner Str. 24
City
Roding
ZIP/Postal Code
93426
Country
Germany
Facility Name
Berneckstrasse 19
City
Schrammberg
ZIP/Postal Code
78713
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs