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Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

Primary Purpose

Diphtheria, Poliomyelitis, Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pediarix TM, Infanrix penta TM
Hiberix TM
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • Major congenital defects
  • Serious chronic illness
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Acute disease at the time of enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Anti-PT, anti-FHA and anti-PRN antibody titers.
    Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
    Anti-HBs antibody titers
    Anti-polio virus types 1, 2 and 3 antibody titers
    Anti-PRP antibody titers

    Secondary Outcome Measures

    Occurrence of solicited adverse events
    Occurrence of unsolicited adverse events
    Occurrence of Serious Adverse Events

    Full Information

    First Posted
    April 9, 2009
    Last Updated
    September 6, 2016
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00879827
    Brief Title
    Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
    Official Title
    Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2000 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    May 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diphtheria, Poliomyelitis, Hepatitis B, Tetanus, Acellular Pertussis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Group
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    Pediarix TM, Infanrix penta TM
    Intervention Description
    The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
    Intervention Type
    Biological
    Intervention Name(s)
    Hiberix TM
    Intervention Description
    The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
    Primary Outcome Measure Information:
    Title
    Anti-PT, anti-FHA and anti-PRN antibody titers.
    Time Frame
    One month after the 3rd dose of the primary vaccination course
    Title
    Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
    Time Frame
    One month after the 3rd dose of the primary vaccination course
    Title
    Anti-HBs antibody titers
    Time Frame
    One month after the 3rd dose of the primary vaccination course
    Title
    Anti-polio virus types 1, 2 and 3 antibody titers
    Time Frame
    One month after the 3rd dose of the primary vaccination course
    Title
    Anti-PRP antibody titers
    Time Frame
    One month after the 3rd dose of the primary vaccination course
    Secondary Outcome Measure Information:
    Title
    Occurrence of solicited adverse events
    Time Frame
    During the 4-day follow-up period after each dose
    Title
    Occurrence of unsolicited adverse events
    Time Frame
    During the 30-day follow-up period after each dose
    Title
    Occurrence of Serious Adverse Events
    Time Frame
    Over the course of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Weeks
    Maximum Age & Unit of Time
    8 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: A male or female infant between 6 and 8 weeks of age at the time of the first vaccination. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Written informed consent obtained from the parents or guardians of the subject. Born after a normal gestation period (between 36 and 42 weeks). Exclusion Criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study. Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after. Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b. History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. Major congenital defects Serious chronic illness History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute disease at the time of enrollment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
    Citations:
    PubMed Identifier
    21621155
    Citation
    Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group; Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.
    Results Reference
    background
    Links:
    URL
    https://www.clinicalstudydatarequest.com
    Description
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Dataset Specification
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/049
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/049
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/049
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/049
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Clinical Study Report
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/049
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register

    Learn more about this trial

    Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

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