Hepatitis B Vaccine Booster Study (V232-058)

Hepatitis B Clinical Trial

Official title:

A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00393523
• Other study ID #: V232-058
• Secondary ID: 2006_040
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2006
• Last updated: February 26, 2015
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1478
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 8 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Biological:
• Comparator: Modified Process Hepatitis B Vaccine
Single dose 5 µg/0.5ml modified process hepatitis B vaccine
• Comparator: Comparator: ENGERIX-B
Single dose 10 µg/0.5ml ENGERIX-B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Diez-Domingo J, Flores SA, Martin JC, Klopfer SO, Schödel 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy	Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™	4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B	No
Other	Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy	Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™	4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B	No
Primary	Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy	Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen =10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.	4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B	No
Secondary	Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy	Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen =10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.	4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site