Trial record 138 of 435 for:    hepatitis b | Open Studies

Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02112890
First received: April 10, 2014
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Hepatitis A
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV [ Time Frame: During the study (approximately 12 months) ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: During the study (approximately 12 months) ] [ Designated as safety issue: No ]
  • Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies [ Time Frame: During the study (approximately 12 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: During the study (approximately 12 months) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stored serum samples of the selected subjects obtained from the ENSANUT 2012


Estimated Enrollment: 2000
Study Start Date: September 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Group
A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) that participated in the ENSANUT 2012 in Mexico.
Other: Data collection
Data of the selected subjects (through structured questionnaires and interviews) and stored serum samples obtained from the ENSANUT 2012. A subset database will be designed by the NIPH for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in the study database.

Detailed Description:

A random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) will be selected from the total population that participated in the Encuesta Nacional de Salud y Nutrición (ENSANUT) 2012 in Mexico.

Data (through structured questionnaires and interviews) and stored serum samples of the selected subjects obtained from the ENSANUT 2012 will be used in this study. A subset database will be designed by the National Institute of Public Health (NIPH) for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in this database.

  Eligibility

Ages Eligible for Study:   10 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects constituting adolescents and young adults (≥10 - ≤25 years of age) from the total population that participated in the ENSANUT 2012 in Mexico.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112890

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02112890     History of Changes
Other Study ID Numbers: 201076
Study First Received: April 10, 2014
Last Updated: August 28, 2014
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Keywords provided by GlaxoSmithKline:
Mexico
Adolescents
Hepatitis
Seroprevalence
Pertussis
Young adults

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014