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Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160081
First received: July 8, 2010
Last updated: January 22, 2011
Last verified: November 2010

July 8, 2010
January 22, 2011
March 2010
September 2010   (final data collection date for primary outcome measure)
  • Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off. [ Time Frame: 6 to 10 months from study initiation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off [ Time Frame: 6 to 10 months from study initiation ] [ Designated as safety issue: No ]
  • Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off [ Time Frame: 6 to 10 months from study initiation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01160081 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico

The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV), Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella pertussis (BP)infections in Mexico.

In order to document the epidemiological changes in the sero-prevalence of Hepatitis A, Human simplex virus (1 and 2), Varicella-Zoster virus and Cytomegalovirus infections, we propose to conduct a population based, seroprevalence, cross-sectional study, in Mexico. This will allow the identification of susceptible populations, which in turn, will serve as evidence for the elaboration of recommendations for the prevention of Hepatitis A, Human simplex virus, Varicella-Zoster virus and Cytomegalovirus infection in the region.

This study was conducted using data and serum samples from a random sample of subjects that participated in the 2006 National Health and Nutrition Survey.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum samples

Probability Sample

The study population will include a random sample of 4000 subjects of subjects who participated in the 2006 National Health and Nutrition Survey (ENSANUT).

  • Viral Hepatitis Vaccines
  • Hepatitis A
  • Cytomegalovirus
  • Varicella-Zoster Virus
  • Bordetella Pertussis Infection
  • Herpes Simplex (1 and 2)
Other: Serum sample
Serum samples collected
National Health and Nutrition Survey 2006 (ENSANUT 2006)
Intervention: Other: Serum sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3658
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
1 Year to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01160081
113564
Not Provided
E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP