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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

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Grieskirchner Strasse 17
Wels, , 4600 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Serogroup C Meningococcal Meninigitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
5-22 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00161941
Pfizer
Completed
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

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Descriptive Information
Brief TitleFollow-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 TitleOpen-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 SummaryThe 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 DescriptionNot Provided
Study TypeObservational
Study DesignNot Provided
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionMeningococcal Meninigitis, Serogroup C
InterventionNot Provided
Study Groups/CohortsNot 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 StatusCompleted
Enrollment
 (submitted: October 19, 2006)
321
Original EnrollmentNot Provided
Study Completion DateDecember 2003
Primary Completion DateNot 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
Ages5 Months to 22 Months   (Child)
Accepts Healthy VolunteersYes
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesAustria,   Germany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00161941
Other Study ID Numbers224
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Principal Investigator:Ulrich Behre, MDPrivate practice, Hauptstrasse, Kehl, Germany
PRS AccountPfizer
Verification DateMay 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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