Clinical trial NCT01706224: Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals
Official title: Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertussis
Keywords: Pertussis antibodies
Bordetella pertussis
sero-prevalence
Healthcare professionals (HCP)
Spain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare professionals actively working and involved with patient care in Spanish hospitals.

Brief summary: This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the subject.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Male and female healthcare professionals aged ≥18 years from selected hospitals.
* Healthcare professionals in frequent contact with patients in the hospitals.
* Agreeing for collection of a blood sample for the study.

Exclusion Criteria:

• Medical students working as healthcare professionals.

Primary outcomes:
measure: Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seropositivity status.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seronegativity status.
timeFrame: Day 0 of each subject at the time of enrollment.
Secondary outcomes:
measure: Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by vaccination history.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by previous history of pertussis.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Description of the knowledge and beliefs about whooping cough and vaccination against pertussis among healthcare professionals.
timeFrame: Day 0 of each subject at the time of enrollment.
measure: Description of the household composition of healthcare professionals to identify the proportion of healthcare professionals potentially at a higher risk of contracting and transmitting pertussis.
timeFrame: Day 0 of each subject at the time of enrollment.
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Majadahonda
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rodriguez de la Pinta ML, Castro Lareo MI, Ramon Torrell JM, Garcia de Lomas J, Devadiga R, Reyes J, McCoig C, Tafalla M, Garcia-Corbeira P. Seroprevalence of pertussis amongst healthcare professionals in Spain. Vaccine. 2016 Feb 17;34(8):1109-14. doi: 10.1016/j.vaccine.2015.12.036. Epub 2015 Dec 22.