Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
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ClinicalTrials.gov Identifier: NCT00393523 |
Recruitment Status :
Completed
First Posted : October 27, 2006
Results First Posted : October 12, 2009
Last Update Posted : April 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B | Biological: Comparator: Modified Process Hepatitis B Vaccine Biological: Comparator: Comparator: ENGERIX-B | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1478 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

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 |
- Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]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™.
- Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]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™.
- Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]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™
- Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy [ Time Frame: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B ]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™

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Ages Eligible for Study: | 4 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393523
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00393523 |
Other Study ID Numbers: |
V232-058 2006_040 |
First Posted: | October 27, 2006 Key Record Dates |
Results First Posted: | October 12, 2009 |
Last Update Posted: | April 12, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
Hepatitis A Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |