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Completed

NCT Number: NCT02112890

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

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.

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Key information

Conditions

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

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Cuernavaca, Morelos, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

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)

    Time frame: During the study (approximately 12 months)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2014
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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