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Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

Primary Purpose

Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
DTPa-HBV-IPV/Hib (Infanrix hexa™)
OPV
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine

Eligibility Criteria

12 Weeks - 16 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study.

  • Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.

Exclusion Criteria:

The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn.

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group A

    Arm Description

    Outcomes

    Primary Outcome Measures

    Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values

    Secondary Outcome Measures

    Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
    Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
    Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
    Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
    Number of subjects with solicited and unsolicited adverse events
    Number of subjects with serious adverse events

    Full Information

    First Posted
    October 20, 2011
    Last Updated
    August 4, 2016
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01457560
    Brief Title
    Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine
    Official Title
    Study to Assess the Immunogenicity and Reactogenicity of DTPa-HBV-IPV Mixed With Hib Vaccine in Healthy Infants, Followed by a Dose of the Same Vaccine Administered Simultaneously With One Dose of Oral Polio Vaccine (OPV)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2000 (undefined)
    Primary Completion Date
    April 2001 (Actual)
    Study Completion Date
    April 2001 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    This study will assess the immunogenicity and safety of the GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') combined DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine administered in the 3rd, 5th, 11th month of life. The last dose of DTPa-HBV-IPV/Hib will be given simultaneously with one dose of OPV vaccine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis
    Keywords
    Oral polio vaccine (OPV), DTPa-HBV-IPV/Hib vaccine

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Intervention Type
    Biological
    Intervention Name(s)
    DTPa-HBV-IPV/Hib (Infanrix hexa™)
    Intervention Description
    Three doses administered intramuscularly
    Intervention Type
    Biological
    Intervention Name(s)
    OPV
    Intervention Description
    One dose administered orally
    Primary Outcome Measure Information:
    Title
    Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
    Time Frame
    One month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9)
    Secondary Outcome Measure Information:
    Title
    Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with antibody titres greater than or equal to cut off values
    Time Frame
    Before the first dose ( Month 0 )
    Title
    Immunogenicity with respect to the components of the study vaccine in terms of antibody titers
    Time Frame
    Before the first dose (Month 0), one month after the second dose and one month after the third dose of the primary vaccination course ( Month 3 and Month 9).
    Title
    Immunogenicity with respect to the components of the study vaccine in terms of number of subjects with vaccine response
    Time Frame
    One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
    Title
    Immunogenicity with respect to the components of the study vaccine in terms of antibody titres greater than or equal to cut off values
    Time Frame
    One month after the second dose, and one month after the third dose of the primary vaccination course (Month 3 and Month 9).
    Title
    Number of subjects with solicited and unsolicited adverse events
    Time Frame
    After each dose of the study vaccines (Month 0, Month 3 and Month 9) and overall
    Title
    Number of subjects with serious adverse events
    Time Frame
    During the study period (Month 0 to Month 9)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Weeks
    Maximum Age & Unit of Time
    16 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The inclusion criteria will be checked at study entry. If any of these criteria does not apply, the subject is not eligible for inclusion in the study. Healthy male and female subjects in the ≥12 and <16 weeks of life 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/guardians of the infant after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure. Exclusion Criteria: The exclusion criteria will be checked at study entry and at each following visit. If any of these criteria applies at study entry, the subject is not eligible for inclusion in the study. If any of these criteria becomes applicable during the study, the subject should be withdrawn. Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination). Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease. History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Major congenital defects or serious chronic illness. History of seizures or of any neurological disease at study entry. Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period. Acute disease at the time of enrolment.
    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
    22349525
    Citation
    Van Der Meeren O, Kuriyakose S, Kolhe D, Hardt K. Immunogenicity of Infanrix hexa administered at 3, 5 and 11 months of age. Vaccine. 2012 Apr 5;30(17):2710-4. doi: 10.1016/j.vaccine.2012.02.024. Epub 2012 Feb 18.
    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
    Informed Consent Form
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/060
    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
    217744/060
    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
    217744/060
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register
    Available IPD/Information Type
    Dataset Specification
    Available IPD/Information URL
    https://www.clinicalstudydatarequest.com
    Available IPD/Information Identifier
    217744/060
    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
    217744/060
    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 DTPa-HBV-IPV/Hib Vaccine Followed by the Same Vaccine and Oral Polio Vaccine

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