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

Hepatitis A Clinical Trial

Official title:

Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112890
• Other study ID #: 201076
• Status: Completed
• Start date: December 10, 2014
• Est. completion date: May 2, 2016

Study information

• Verified date: June 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1603
• Est. completion date: May 2, 2016
• Est. primary completion date: May 2, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Viral Hepatitis Vaccines
• Whooping Cough

Intervention

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.

Locations

Country	Name	City	State
Mexico	GSK Investigational Site	Cuernavaca	Morelos

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV		During the study (approximately 12 months)
Primary	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)		During the study (approximately 12 months)
Primary	Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies		During the study (approximately 12 months)
Secondary	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)		During the study (approximately 12 months)

External Links

•   Results for study 201076 can be found on the GSK Clinical Study Register