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

NCT02112890 | Completed

• 1 other identifier: 201076
• Study Type: observational
• Target: 1,603
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis A; Viral Hepatitis Vaccines

Keywords

Mexico; Adolescents; Hepatitis; Seroprevalence; Pertussis; Young adults

Outcome Measures

Primary Outcomes (3)

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

  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)

  During the study (approximately 12 months)

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

  During the study (approximately 12 months)

Secondary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Data collection OTHER

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.

Study Group

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cuernavaca, Morelos, Mexico

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Hepatitis A; Hepatitis; Whooping Cough

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: December 10, 2014
• Primary Completion: May 2, 2016
• Study Completion: May 2, 2016
• Last Updated: June 27, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)