Hepatitis ANCT02112890
Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
An observational study of Hepatitis A and Viral Hepatitis Vaccines, run by GlaxoSmithKline at 1 site in Mexico.
Trial summary
This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis A, Viral Hepatitis Vaccines
- What is being tested?
- Data collection
- How many people
- 1,603 participants
- Where
- 1 siteMexico
- Study dates
- 10 Dec 2014to 2 May 2016
- 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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects constituting adolescents and young adults (≥10 - ≤25 years of age) from the total population that participated in the ENSANUT 2012 in Mexico.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
Read the 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.
- Conditions
- Hepatitis A, Viral Hepatitis Vaccines
- Being tested
- Data collection
- Keywords
- Mexico, Adolescents, Hepatitis, Seroprevalence, Pertussis, Young adults
- Medical subject headings
- Hepatitis A, Hepatitis, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV
Measured: During the study (approximately 12 months)
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)
Measured: During the study (approximately 12 months)
Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies
Measured: During the study (approximately 12 months)
Secondary outcomes (1)
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)
Measured: During the study (approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start10 Dec 2014
- Primary completion2 May 2016
- Study completion2 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis AStudies 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112890
- Sponsor's protocol ID
- 201076
- Status last verified
- Jun 2019
- First submitted
- 10 Apr 2014
- Last updated
- 27 Jun 2019
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
- ClinicalTrials.gov ID
- NCT02112890
- Acronym / sponsor ID
- 201076
- Conditions
- Hepatitis A, Viral Hepatitis Vaccines
- Keywords
- Mexico, Adolescents, Hepatitis, Seroprevalence, Pertussis, Young adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,603 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2014 (actual)
- Primary completion
- 2 May 2016 (actual)
- Study completion
- 2 May 2016 (actual)
- First posted
- 14 Apr 2014 (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.
This study will assess the seroprevalence of hepatitis A virus (HAV), hepatitis B virus (HBV) and Bordetella pertussis (B. pertussis) in adolescents and young adults in Mexico.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Data collectionA random sample of subjects constituting adolescents and young adults (≥10 - ≤25 years of age) that participated in the ENSANUT 2012 in Mexico. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects constituting adolescents and young adults (≥10 - ≤25 years of age) from the total population that participated in the ENSANUT 2012 in Mexico.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Data collectionData 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. | Other | Study Group |
Primary outcome
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)
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)
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)
1 secondary outcome
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)
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 27 Jun 2019.
- Results for study 201076 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Hepatitis A and Viral Hepatitis Vaccines, 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 2 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 27 Jun 2019. 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?
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)). The study lists 3 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 27 Jun 2019.