Viral Hepatitis VaccinesNCT01160081
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
An observational study of Viral Hepatitis Vaccines and Hepatitis A, run by GlaxoSmithKline at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus
- What is being tested?
- Serum sample
- How many people
- 3,658 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include a random sample of 4000 subjects of subjects who participated in the 2006 National Health and Nutrition Survey (ENSANUT).
Who may be able to join
- Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus, Varicella-Zoster Virus, Bordetella Pertussis Infection, Herpes Simplex (1 and 2)
- Being tested
- Serum sample
- Medical subject headings
- Hepatitis A, Chickenpox, Whooping Cough, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum sampleOther
Serum samples collected
| Study group | Role | What they receive |
|---|---|---|
| National Health and Nutrition Survey 2006 (ENSANUT 2006) | Not described Receives: Other: Serum sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.
Measured: 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
Measured: 6 to 10 months from study initiation
Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off
Measured: 6 to 10 months from study initiation
Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off
Measured: 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
Measured: 6 to 10 months from study initiation
Secondary outcomes (1)
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)
Measured: 6 to 10 months from study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral Hepatitis VaccinesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 3,658 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160081
- Sponsor's protocol ID
- 113564
- Status last verified
- Nov 2010
- First submitted
- 8 Jul 2010
- Last updated
- 25 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-prevalence of Hepatitis A Varicella-Zoster Virus, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis in Mexico
- ClinicalTrials.gov ID
- NCT01160081
- Acronym / sponsor ID
- 113564
- Conditions
- Viral Hepatitis Vaccines, Hepatitis A, Cytomegalovirus, Varicella-Zoster Virus, Bordetella Pertussis Infection, Herpes Simplex (1 and 2)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,658 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| National Health and Nutrition Survey 2006 (ENSANUT 2006) | – | Other: Serum sample |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include a random sample of 4000 subjects of subjects who participated in the 2006 National Health and Nutrition Survey (ENSANUT).
Key inclusion criteria (1 listed)
- Previously enrolled subjects aged >= 1 to 70 years for National Health and Nutrition Survey 2006 in Mexico, with previously obtained informed consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum sampleSerum samples collected | Other | National Health and Nutrition Survey 2006 (ENSANUT 2006) |
Primary outcome
Anti-HAV seropositivity status: Subjects with anti-HAV antibody titers >= assay cut-off.
Time frame: 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
Time frame: 6 to 10 months from study initiation
Anti-VZV seropositivity status: Subjects with anti-VZV antibody titers >= assay cut-off
Time frame: 6 to 10 months from study initiation
Anti-CMV seropositivity status: Subjects with anti-CMV antibody titers >= assay cut-off
Time frame: 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
Time frame: 6 to 10 months from study initiation
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Hepatitis Vaccines and Hepatitis A, run by GlaxoSmithKline at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2011.