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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis B

Treatments: Biological: hepatitis B vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00335881

106745

Details and patient eligibility

About

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

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)