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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

Tracking Information
First Submitted Date September 8, 2005
First Posted Date September 13, 2005
Last Update Posted Date May 21, 2015
Study Start Date June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Meningococcal Meninigitis, Serogroup C
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: October¬†19,¬†2006)
321
Original Enrollment Not Provided
Study Completion Date December 2003
Primary Completion Date Not Provided
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Months to 22 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00161941
Other Study ID Numbers 224
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Principal Investigator: Ulrich Behre, MD Private practice, Hauptstrasse, Kehl, Germany
PRS Account Pfizer
Verification Date May 2015