Clinical trial NCT00393523: Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Official title: A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-10-27
Enrollment: 1478
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B. The primary vaccination series (was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product (either RECOMBIVAX HB or ENGERIX-B). The booster dose given in this study will be either an investigational Merck product (Modified Process Hepatitis B Vaccine) or licensed ENGERIX-B vaccine.


Eligibility criteria: Inclusion Criteria:

* Healthy Children 4 to 8 years of age
* Complete medical records documenting receiving a previous hepatitis B vaccination during the first year of life (for Cohort A and B only)
* Complete 3-dose vaccination with either a primary series of RECOMBIVAX HB or a primary series of ENGERIX-B (for Cohort A and B only)

Exclusion Criteria:

* Birth mother known to be a carrier of hepatitis B virus (Cohort C only)
* History of previous hepatitis B vaccine
* History of vaccination with any hepatitis B vaccine (Cohort C only)
* Known of suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (eg aluminum, yeast) recent administration of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
* Receipt of investigational drugs or vaccines within 3 months prior to study vaccine or planned within study period
* Impairment of immunologic function or recent use of immunomodulatory medications
* A Combination of different hepatitis B vaccines used in the primary vaccination series (Cohort A and B only)

Primary outcomes:
measure: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
timeFrame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Secondary outcomes:
measure: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
timeFrame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Other outcomes:
measure: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
timeFrame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
measure: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
timeFrame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schodel FP, Bhuyan PK. A randomized, multicenter, open-label clinical trial to assess the anamnestic immune response 4 to 8 years after a primary hepatitis B vaccination series. Pediatr Infect Dis J. 2010 Oct;29(10):972-4. doi: 10.1097/INF.0b013e3181f1b3b6.