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 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.

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Key information

Conditions

Meningococcal Meninigitis, Serogroup C Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Bacterial Infections Central Nervous System Diseases Central Nervous System Infections Gram-Negative Bacterial Infections Infections Meningitis Meningitis, Bacterial Meningitis, Meningococcal Meningococcal Infections Neisseriaceae Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

5 month–22 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Grieskirchner Strasse 17, Wels, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Study completion: 2003
First posted: Sep 13, 2005
Registry last updated: May 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed