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Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity

Primary Purpose

Hepatitis A

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A & B, Typhoid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria Written informed consent will be obtained from the subject prior to entry into the study. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Seronegative for anti-HAV antibodies. If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects having received the study vaccines 36 months earlier. Exclusion criteria 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. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >or = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.). Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. History of chronic alcohol consumption and/or intravenous drug abuse. Previous vaccination against hepatitis A. Previous vaccination against typhoid fever. History of hepatitis A. Previous diagnosis, confirmed by a physician, of Salmonella typhi infection. History of non-response to hepatitis A and or typhoid vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature < 99.5 °F (37.5 °C) Female planning to become pregnant during the primary study period (up Month 7). Pregnant or lactating female. Planned travel to areas of high endemicity for hepatitis A and/ or typhoid fever during the primary study period (up Month 7).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Anti-Vi seropositivity rates (i.e., percentage of subjects with anti-Vi antibody titres > or = 150 EL.U/ml) at Month 1 after administration of study vaccine (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Typhim Vi).
    Anti-HAV seropositivity rates (i.e., percentage of subjects with anti-HAV antibody titres >or = 15 mIU/ml) at Month 1 after administration of study vaccine, (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Havrix).

    Secondary Outcome Measures

    Anti-Vi seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
    Anti-HAV seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
    Anti-Vi and anti-HAV seropositivity rates and GMTs at Months 12, 24, 36 after administration of study vaccine.
    Occurrence and intensity of solicited local symptoms after vaccination (Day 0 to 4).
    Occurrence, intensity and relationship of solicited general symptoms after vaccination (Day 0 to 4).
    Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms after vaccination (Day 0 to 30).
    Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) during the study period and during the follow-up period up to Months 12, 24 and 36 after administration of study vaccine.

    Full Information

    First Posted
    September 15, 2005
    Last Updated
    September 8, 2016
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00197249
    Brief Title
    Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity
    Official Title
    A Phase III, Open, Randomized, Multicentric Study to Compare the Reactogenicity and Immunogenicity of GSK Biologicals' Combined Vi Polysaccharide Typhoid Vaccine and Inactivated Hepatitis A Vaccine, to That Elicited by GSK Biologicals' Hepatitis A Vaccine, Administered Singly or Concomitantly With GSK Biologicals' Vi Polysaccharide Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2002 (undefined)
    Primary Completion Date
    June 2003 (Actual)
    Study Completion Date
    November 2005 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine.
    Detailed Description
    Compare the reactogenicity & immunogenicity of GSK Biologicals' combined Vi polysaccharide typhoid vaccine & inactivated hepatitis A vaccine, Hepatyrix, to that elicited by GSK Biologicals' hepatitis A vaccine, Havrix administered singly or concomitantly with GSK Biologicals' Vi polysaccharide vaccine, Typherix, & to that elicited by Aventis Pasteur's monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy subjects aged 18-65 yrs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis A
    Keywords
    Hepatitis A & B, Typhoid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1034 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix
    Primary Outcome Measure Information:
    Title
    Anti-Vi seropositivity rates (i.e., percentage of subjects with anti-Vi antibody titres > or = 150 EL.U/ml) at Month 1 after administration of study vaccine (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Typhim Vi).
    Title
    Anti-HAV seropositivity rates (i.e., percentage of subjects with anti-HAV antibody titres >or = 15 mIU/ml) at Month 1 after administration of study vaccine, (Comparison of Hepatyrix versus concomitant Havrix+Typherix and Hepatyrix versus Havrix).
    Secondary Outcome Measure Information:
    Title
    Anti-Vi seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
    Title
    Anti-HAV seropositivity rates at Day 14, Month 6 and Month 7 and GMTs at Day 14, Month 1, Month 6 and Month 7 after administration of study vaccine.
    Title
    Anti-Vi and anti-HAV seropositivity rates and GMTs at Months 12, 24, 36 after administration of study vaccine.
    Title
    Occurrence and intensity of solicited local symptoms after vaccination (Day 0 to 4).
    Title
    Occurrence, intensity and relationship of solicited general symptoms after vaccination (Day 0 to 4).
    Title
    Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms after vaccination (Day 0 to 30).
    Title
    Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs) during the study period and during the follow-up period up to Months 12, 24 and 36 after administration of study vaccine.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria Written informed consent will be obtained from the subject prior to entry into the study. Free of obvious health problems as established by medical history and clinical examination before entering into the study. Seronegative for anti-HAV antibodies. If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects having received the study vaccines 36 months earlier. Exclusion criteria 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. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >or = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.). Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s). Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. History of chronic alcohol consumption and/or intravenous drug abuse. Previous vaccination against hepatitis A. Previous vaccination against typhoid fever. History of hepatitis A. Previous diagnosis, confirmed by a physician, of Salmonella typhi infection. History of non-response to hepatitis A and or typhoid vaccine. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature < 99.5 °F (37.5 °C) Female planning to become pregnant during the primary study period (up Month 7). Pregnant or lactating female. Planned travel to areas of high endemicity for hepatitis A and/ or typhoid fever during the primary study period (up Month 7).
    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.
    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
    270362/006
    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
    270362/006
    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
    270362/006
    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
    270362/006
    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
    270362/006
    Available IPD/Information Comments
    For additional information about this study please refer to the GSK Clinical Study Register

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    Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity

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