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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01160081 |
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Date of registration:
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08/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
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Scientific title:
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Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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3658 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01160081 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Mexico
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
• Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition
Survey 2006 in Mexico, with previously obtained informed consent
Exclusion Criteria:
- Information required for the study is not available or incomplete.
- Inadequate or insufficient serum sample to detect viral agents required for the
study.
- Serum sample wrongly identified.
Age minimum:
1 Year
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis A
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Viral Hepatitis Vaccines
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Cytomegalovirus
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Herpes Simplex (1 and 2)
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Bordetella Pertussis Infection
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Varicella-Zoster Virus
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Intervention(s)
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Other: Serum sample
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Primary Outcome(s)
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Anti-HSV seropositivity status (defined as the percentage of subjects with anti-HSV 1 and 2 titers >= assay cut-off): Subjects with anti-HSV antibody titers >= assay cut-off
[Time Frame: 6 to 10 months from study initiation]
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Anti-Pertussis Toxin seropositivity status for IgG and IgA: Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgG, Subjects with anti-Pertussis Toxin antibody titers >= assay cut-off for IgA
[Time Frame: 6 to 10 months from study initiation]
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Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off
[Time Frame: 6 to 10 months from study initiation]
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Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.
[Time Frame: 6 to 10 months from study initiation]
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Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off
[Time Frame: 6 to 10 months from study initiation]
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Secondary Outcome(s)
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Difference in HAV, VZV, CMV , HSV and BP seropositivity rates according to socioeconomic status, age group, gender, region, risk group, area and pertussis vaccination status (only for BP analysis)
[Time Frame: 6 to 10 months from study initiation]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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