- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02112890
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Morelos
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Cuernavaca, Morelos, Mexico
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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During the study (approximately 12 months)
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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)
|
During the study (approximately 12 months)
|
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)
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During the study (approximately 12 months)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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During the study (approximately 12 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Whooping Cough
- Hepatitis
- Hepatitis A
Other Study ID Numbers
- 201076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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