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A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Modified Process Hepatitis B Vaccine (Experimental)
Hepatitis B Vaccine (Recombinant)
Hepatitis B Vaccine (Recombinant)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

2 Months - 2 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant is a healthy infant approximately 2 months of age

Exclusion Criteria:

  • Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
  • Participant's birth mother did not receive any prenatal care
  • Participant has previous history of hepatitis B infection
  • Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
  • Participant has had a fever within 72 hours of study start
  • Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    Modified Process Hepatitis B vaccine 5 μg

    RECOMBIVAX HB™ Hepatitis B Vaccine

    Modified Process Hepatitis B vaccine 10 μg

    ENGERIX-B®

    Arm Description

    Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.

    Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.

    Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.

    Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.

    Outcomes

    Primary Outcome Measures

    The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
    The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.

    Secondary Outcome Measures

    Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®
    Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.

    Full Information

    First Posted
    December 20, 2006
    Last Updated
    April 12, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00414050
    Brief Title
    A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
    Official Title
    A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 6, 2006 (Actual)
    Primary Completion Date
    October 22, 2007 (Actual)
    Study Completion Date
    October 24, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1718 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified Process Hepatitis B vaccine 5 μg
    Arm Type
    Experimental
    Arm Description
    Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age.
    Arm Title
    RECOMBIVAX HB™ Hepatitis B Vaccine
    Arm Type
    Active Comparator
    Arm Description
    Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age.
    Arm Title
    Modified Process Hepatitis B vaccine 10 μg
    Arm Type
    Experimental
    Arm Description
    Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age.
    Arm Title
    ENGERIX-B®
    Arm Type
    Active Comparator
    Arm Description
    Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age.
    Intervention Type
    Biological
    Intervention Name(s)
    Modified Process Hepatitis B Vaccine (Experimental)
    Intervention Description
    Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).
    Intervention Type
    Biological
    Intervention Name(s)
    Hepatitis B Vaccine (Recombinant)
    Other Intervention Name(s)
    RECOMBIVAX HB™
    Intervention Description
    RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Hepatitis B Vaccine (Recombinant)
    Other Intervention Name(s)
    ENGERIX-B®
    Intervention Description
    ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
    Primary Outcome Measure Information:
    Title
    The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
    Description
    The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
    Time Frame
    7 months of age (1 month after 3 doses)
    Secondary Outcome Measure Information:
    Title
    Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®
    Description
    Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.
    Time Frame
    7 months of age (1 month after 3 doses)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    2 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participant is a healthy infant approximately 2 months of age Exclusion Criteria: Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant Participant's birth mother did not receive any prenatal care Participant has previous history of hepatitis B infection Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant Participant has had a fever within 72 hours of study start Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    21552183
    Citation
    Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.
    Results Reference
    result

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    A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)

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