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Completed

NCT Number: NCT00335881

Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Bad Saulgau, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • A male or female aged 4 to 6 years at the time of study entry .
  • Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine in previous vaccination studies.
  • Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib vaccine.

Treatment and study plan

Hepatitis B vaccine

Biological

Primary outcomes

  1. Anti-HBs antibody concentration

Secondary outcomes

  1. Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.

  2. Sol & unsol symptoms after HBV vaccination, SAEs

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 4 to 6 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Important dates

Study start
2006
Study completion
2006
First posted
Jun 12, 2006
Registry last updated
Oct 7, 2016

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.

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