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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Comparator: Modified Process Hepatitis B Vaccine Biological: Comparator: Comparator: ENGERIX-B Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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™.


Secondary Outcome Measures :
  1. 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™.


Other Outcome Measures:
  1. 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™

  2. 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™


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications of Results:

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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
Additional relevant MeSH terms:
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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