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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00161941

Enrollment

321

Registered

2005-09-13

Start date

2003-06-30

Completion date

2003-12-31

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Meninigitis, Serogroup C

Keywords

Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

5 Months to 22 Months

Healthy volunteers

Yes

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.

Countries

Austria, Germany

Outcome results