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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Comparator: Modified Process Hepatitis B Vaccine; Biological: Comparator: Comparator: ENGERIX-B

• Study Type: Interventional
• Enrollment (Actual): 1478
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1); Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose).	Biological: Comparator: Modified Process Hepatitis B Vaccine; Single dose 5 µg/0.5ml modified process hepatitis B vaccine
Active Comparator: 10 µg ENGERIX-B™ Booster (Group 2); Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose)	Biological: Comparator: Comparator: ENGERIX-B; Single dose 10 µg/0.5ml ENGERIX-B
Active Comparator: 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3); Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose).	Biological: Comparator: Modified Process Hepatitis B Vaccine; Single dose 5 µg/0.5ml modified process hepatitis B vaccine
Active Comparator: 10 µg ENGERIX-B™ Booster (Group 4); Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose).	Biological: Comparator: Comparator: ENGERIX-B; Single dose 10 µg/0.5ml ENGERIX-B
Experimental: 5 µg Modified Process Hepatitis B Vaccine (Group 5); Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine.	Biological: Comparator: Modified Process Hepatitis B Vaccine; Single dose 5 µg/0.5ml modified process hepatitis B vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: October 25, 2006
• First Submitted That Met QC Criteria: October 25, 2006
• First Posted (Estimate): October 27, 2006

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: V232-058; 2006_040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php