Last updated: 10/01/2021 12:20:08

Study to assess seroprevalence of Hepatitis A, Hepatitis B and Bordetella pertussis in Mexico

GSK study ID
201076
See study documents
Clinicaltrials.gov ID
NCT02112890
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: Seroprevalence of Hepatitis A, Hepatitis B and Bordetella pertussis in Mexico
Trial description: This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV

Timeframe: During the study (approximately 12 months)

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HBV (Hepatitis B core antibody [anti-HBc], Hepatitis B surface antigen [HBsAg]) and Hepatitis B surface antibody (anti-HBs)

Timeframe: During the study (approximately 12 months)

Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies

Timeframe: During the study (approximately 12 months)

Secondary outcomes:

Assesment of the difference in HAV, HBV and B. pertussis seropositivity rates among - Socioeconomic strata, - Regions, - Age groups, - Genders, - Risk groups, - Vaccination status for B. pertussis (if available)

Timeframe: During the study (approximately 12 months)

Interventions:
  • Other: Data collection
    • Enrollment:
    1603
    Primary completion date:
    2016-02-05
    Observational study model:
    Case-Only
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Echaniz-Avilés IG, Garcia-Cisneros S, Sanchez-Aleman M, Olamendi-Portugal M, Romero-Martínez M, DeAntonio R, Cervantes Y, Ortega E, Cortes-Alcala R, Alpuche-Aranda CM. An observational, cross-sectional study to assess the seroprevalence of Bordetella pertussis in adolescents and young adults in Mexico. Vaccine. 2021; DOI: http://dx.doi.org/ https://doi.org/10.1016/j.vaccine.2021.08.063
    Medical condition
    Hepatitis A
    Product
    SB208109
    Collaborators
    Not applicable
    Study date(s)
    December 2014 to May 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    10 - 25 years
    Accepts healthy volunteers
    Yes
    • Written informed consent for the ENSANUT 2012 was obtained according to local regulations from the subject/ from the parent(s)/ legally acceptable representative (LAR) of the subject.
    • A male or female between and including 10 and 25 years of age, who previously participated in the ENSANUT 2012 in Mexico.
    • Information required for the study is not available or incomplete.
    • Inadequate or insufficient serum sample to perform the laboratory tests for this study.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Written informed consent for the ENSANUT 2012 was obtained according to local regulations from the subject/ from the parent(s)/ legally acceptable representative (LAR) of the subject.

      • A male or female between and including 10 and 25 years of age, who previously participated in the ENSANUT 2012 in Mexico.
    Exclusion criteria:

      Information required for the study is not available or incomplete.

      • Inadequate or insufficient serum sample to perform the laboratory tests for this study.
      • Serum sample is wrongly identified.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cuernavaca, Morelos, Mexico, 62100
    Status
    Study Complete
    Contact us

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)
    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
    2016-02-05
    Actual study completion date
    2016-02-05

    Plain language summaries

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

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 201076 can be found on the GSK Clinical Study Register
    Click here
    Access to clinical trial data by researchers
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