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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 March 14, 2019

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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.
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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.
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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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