Last updated: 11/07/2018 06:24:16

Seroprevalence study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella pertussis

GSK study ID
113564
See study documents
Clinicaltrials.gov ID
NCT01160081
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Sero-prevalence of Hepatitis A Varicella-Zoster virus, Cytomegalovirus, Herpes Simplex and Bordetella pertussis in Mexico
Trial description: The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.

Timeframe: 6 to 10 months from study initiation

Anti-Pertussis Toxin seropositivity status for IgG and IgA: Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgG, Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgA

Timeframe: 6 to 10 months from study initiation

Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off

Timeframe: 6 to 10 months from study initiation

Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off

Timeframe: 6 to 10 months from study initiation

Anti-HSV seropositivity status (defined as the percentage of subjects with anti-HSV 1 and 2 titers >= assay cut-off): Subjects with anti-HSV antibody titers >= assay cut-off

Timeframe: 6 to 10 months from study initiation

Secondary outcomes:

Difference in HAV, VZV, CMV , HSV and BP seropositivity rates according to socioeconomic status, age group, gender, region, risk group, area and pertussis vaccination status (only for BP analysis)

Timeframe: 6 to 10 months from study initiation

Interventions:
  • Other: Serum sample
    • Enrollment:
    3658
    Primary completion date:
    2010-03-09
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Conde-Glez C et al. (2013) Seroprevalences of varicella-zoster virus, herpes simplex virus and cytomegalovirus in a cross-sectional study in Mexico. 31(44):5067-5074.
    Conde-Glez C et al. (2014) Seroprevalence of Bordetella pertussis in the Mexican population: a cross-sectional study. Epidemiol Infect. 142(4):706-713.
    Lazcano-Ponce E et al. (2013) Seroprevalence of hepatitis A virus in a cross-sectional study in Mexico: Implications for hepatitis A vaccination. Hum Vaccin Immunother. 9(2). 375-381.
    Medical condition
    Viral Hepatitis Vaccines, Cytomegalovirus, Varicella-Zoster Virus, Bordetella pertussis infection, Herpes Simplex (1 and 2)
    Product
    SB208109
    Collaborators
    Not applicable
    Study date(s)
    March 2010 to September 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    1 - 70 years
    Accepts healthy volunteers
    Yes
    • Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent
    • Information required for the study is not available or incomplete.
    • Inadequate or insufficient serum sample to detect viral agents required for the study.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent

    Exclusion criteria:

      Information required for the study is not available or incomplete.

      • Inadequate or insufficient serum sample to detect viral agents required for the study.
      • Serum sample wrongly identified.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cuernavaca, Morelos, Mexico
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-03-09
    Actual study completion date
    2010-03-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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