Phase 3 N=1,478 Randomized Single-blind Prevention

Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)

Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT00393523 ↗

Enrolled (actual)

1,478

Serious AEs

0.1%

Results posted

Oct 2009

Primary outcome: Primary: Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy — 323; 305 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: Modified Process Hepatitis B Vaccine (Biological); Comparator: Comparator: ENGERIX-B (Biological)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy	476.9; 561.2	—
SECONDARY Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy	1424.0; 1216.1	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00393523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.