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Completed

NCT Number: NCT00393523

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comparator: Modified process Hepatitis B Vaccine

Biological

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

Comparator: Comparator: ENGERIX-B

Biological

Single dose 10 µg/0.5ml ENGERIX-B

Primary outcomes

  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 outcomes

  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 outcomes

  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™

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 27, 2006
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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