Clinical trial NCT02112890: Study to Assess Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
Official title: Seroprevalence of Hepatitis A, Hepatitis B and Bordetella Pertussis in Mexico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis A
Viral Hepatitis Vaccines
Keywords: Mexico
Adolescents
Hepatitis
Seroprevalence
Pertussis
Young adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 1603
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for anti-HAV
timeFrame: During the study (approximately 12 months)
measure: 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)
timeFrame: During the study (approximately 12 months)
measure: Assessment of seropositivity status (defined as the percentage of subjects with antibody titres positive) for Pertussis antibodies
timeFrame: During the study (approximately 12 months)
Secondary outcomes:
measure: 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)
timeFrame: During the study (approximately 12 months)
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: GSK Investigational Site
state: Morelos
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: