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
NCT00161941
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
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Descriptive Information | ||||
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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 | 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:
Exclusion Criteria: Study subjects will be excluded from participation in this study if:
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Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | May 2015 |