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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00335881

Enrollment

300

Registered

2006-06-12

Start date

2006-06-30

Completion date

2006-11-30

Last updated

2016-10-07

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

Conditions

Hepatitis B

Keywords

Prophylaxis for hepatitis B disease

Brief summary

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

Interventions

BIOLOGICALhepatitis B vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Anti-HBs antibody concentration	—

Secondary

Measure	Time frame
Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.	—
Sol & unsol symptoms after HBV vaccination, SAEs	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026