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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Biological: Comparator: Comparator: ENGERIX-B; Biological: Comparator: Modified Process Hepatitis B Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00393523

V232-058

2006_040

Details and patient eligibility

About

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.

Enrollment: 1,478 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,478 participants in 5 patient groups

5 µg Modified Process Hepatitis B Vaccine Booster (Group 1)

Active Comparator group

Description:

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).

Treatment:

Biological: Comparator: Modified Process Hepatitis B Vaccine

10 µg ENGERIX-B™ Booster (Group 2)

Active Comparator group

Description:

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)

Treatment:

Biological: Comparator: Comparator: ENGERIX-B

5 µg Modified Process Hepatitis B Vaccine Booster (Group 3)

Active Comparator group

Description:

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).

Treatment:

Biological: Comparator: Modified Process Hepatitis B Vaccine

10 µg ENGERIX-B™ Booster (Group 4)

Active Comparator group

Description:

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).

Treatment:

Biological: Comparator: Comparator: ENGERIX-B

5 µg Modified Process Hepatitis B Vaccine (Group 5)

Experimental group

Description:

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.

Treatment:

Biological: Comparator: Modified Process Hepatitis B Vaccine