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

NCT ID: NCT00393523

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1478 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-06-30

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Comparator: Modified Process Hepatitis B Vaccine

Intervention Type: BIOLOGICAL

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

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)

Group Type: ACTIVE_COMPARATOR

Comparator: Comparator: ENGERIX-B

Intervention Type: BIOLOGICAL

Single dose 10 µg/0.5ml ENGERIX-B

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).

Group Type: ACTIVE_COMPARATOR

Comparator: Modified Process Hepatitis B Vaccine

Intervention Type: BIOLOGICAL

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

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).

Group Type: ACTIVE_COMPARATOR

Comparator: Comparator: ENGERIX-B

Intervention Type: BIOLOGICAL

Single dose 10 µg/0.5ml ENGERIX-B

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.

Group Type: EXPERIMENTAL

Comparator: Modified Process Hepatitis B Vaccine

Intervention Type: BIOLOGICAL

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

Interventions

Comparator: Modified Process Hepatitis B Vaccine

Single dose 5 µg/0.5ml modified process hepatitis B vaccine

Intervention Type: BIOLOGICAL

Comparator: Comparator: ENGERIX-B

Single dose 10 µg/0.5ml ENGERIX-B

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 20724955 (View on PubMed)

Other Identifiers

2006_040

Identifier Type: -

Identifier Source: secondary_id

V232-058

Identifier Type: -

Identifier Source: org_study_id