Last updated: 11/07/2018 06:24:16
Seroprevalence study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella pertussis
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Sero-prevalence of Hepatitis A Varicella-Zoster virus, Cytomegalovirus, Herpes Simplex and Bordetella pertussis in Mexico
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.
Timeframe: 6 to 10 months from study initiation
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
Timeframe: 6 to 10 months from study initiation
Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off
Timeframe: 6 to 10 months from study initiation
Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off
Timeframe: 6 to 10 months from study initiation
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
Timeframe: 6 to 10 months from study initiation
Secondary outcomes:
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)
Timeframe: 6 to 10 months from study initiation
Interventions:
Other: Serum sample
Enrollment:
3658
Observational study model:
Other
Primary completion date:
2010-03-09
Time perspective:
Prospective
Clinical publications:
Conde-Glez C et al. (2013) Seroprevalences of varicella-zoster virus, herpes simplex virus and cytomegalovirus in a cross-sectional study in Mexico. 31(44):5067-5074.
Conde-Glez C et al. (2014) Seroprevalence of Bordetella pertussis in the Mexican population: a cross-sectional study. Epidemiol Infect. 142(4):706-713.
Lazcano-Ponce E et al. (2013) Seroprevalence of hepatitis A virus in a cross-sectional study in Mexico: Implications for hepatitis A vaccination. Hum Vaccin Immunother. 9(2). 375-381.
Medical condition
Viral Hepatitis Vaccines, Cytomegalovirus, Varicella-Zoster Virus, Bordetella pertussis infection, Herpes Simplex (1 and 2)
Product
SB208109
Collaborators
Not applicable
Study date(s)
March 2010 to September 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
1 - 70 years
Accepts healthy volunteers
Yes
- Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent
- Information required for the study is not available or incomplete.
- Inadequate or insufficient serum sample to detect viral agents required for the study.
Inclusion and exclusion criteria
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:
- Inadequate or insufficient serum sample to detect viral agents required for the study.
- Serum sample wrongly identified.
Information required for the study is not available or incomplete.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-03-09
Actual study completion date
2010-03-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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