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Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

Primary Purpose

Haemophilus Influenzae Type B, Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: Modified Process Vaccine
Comparator: COMVAX™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type B focused on measuring Haemophilus Influenza, type b and Hepatitis B

Eligibility Criteria

40 Days - 80 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers

Exclusion Criteria:

  • Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
  • History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
  • Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
  • Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
  • Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
  • Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Modified process Hib/Hep B vaccine

    COMVAX™

    Outcomes

    Primary Outcome Measures

    The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
    The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
    Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).

    Secondary Outcome Measures

    The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
    Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)
    The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
    The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
    The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
    Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)

    Full Information

    First Posted
    February 26, 2007
    Last Updated
    March 2, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00441012
    Brief Title
    Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
    Official Title
    A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Haemophilus Influenzae Type B, Hepatitis B
    Keywords
    Haemophilus Influenza, type b and Hepatitis B

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Modified process Hib/Hep B vaccine
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    COMVAX™
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Modified Process Vaccine
    Intervention Description
    Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 & 12 months of age. Duration of treatment is 11 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: COMVAX™
    Intervention Description
    COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.
    Primary Outcome Measure Information:
    Title
    The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
    Description
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
    Time Frame
    11 months (1 month after the third dose)
    Title
    The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
    Description
    Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
    Time Frame
    11 months (1 month after the third dose)
    Secondary Outcome Measure Information:
    Title
    The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
    Description
    Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)
    Time Frame
    0-11 months (recorded from first dose until the participant completes or discontinues)
    Title
    The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
    Description
    The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
    Time Frame
    11 months (1 month after the third dose)
    Title
    The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
    Description
    Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
    Time Frame
    11 months (1 month after the third dose)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Days
    Maximum Age & Unit of Time
    80 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers Exclusion Criteria: Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F) Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast) Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period; Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids); Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21875633
    Citation
    Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schodel FP, Bhuyan PK. Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27.
    Results Reference
    result

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    Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)

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