Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals

Pertussis Clinical Trial

Official title:

Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706224
• Other study ID #: 115539
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: January 9, 2014
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: January 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Intervention

Procedure:
• Blood sample
Samples will be tested to determine the presence of anti-pertussis antibodies.

Other:
• Data collection
Electronic Case Report Forms (eCRF)
• Data collection
Questionnaires, active questioning.

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Hospitalet de Llobregat
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Majadahonda

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels.		Day 0 of each subject at the time of enrollment.	No
Primary	Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seropositivity status.		Day 0 of each subject at the time of enrollment.	No
Primary	Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seronegativity status.		Day 0 of each subject at the time of enrollment.	No
Secondary	Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged = 18 years.	By age and gender, by type of healthcare professional, by hospital department of the healthcare professional, duration of service and time spent with patients.	Day 0 of each subject at the time of enrollment.	No
Secondary	Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by vaccination history.		Day 0 of each subject at the time of enrollment.	No
Secondary	Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by previous history of pertussis.		Day 0 of each subject at the time of enrollment.	No
Secondary	Description of the knowledge and beliefs about whooping cough and vaccination against pertussis among healthcare professionals.		Day 0 of each subject at the time of enrollment.	No
Secondary	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.		Day 0 of each subject at the time of enrollment.	No