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

Completed

• Conditions: Pertussis
• Interventions: Procedure: Blood sample; Other: Data collection

• Registration Number: NCT01706224
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2012-10-11
• Study First Posted: 2012-10-15
• Study Start: 2012-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 757

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Data collection	Subjects in this group will be all physicians actively working at hospital centres in Spain.
Group B	Data collection	Subjects in this group will be all nurses actively working at hospital centres in Spain.
Group A	Blood sample	Subjects in this group will be all physicians actively working at hospital centres in Spain.
Group B	Blood sample	Subjects in this group will be all nurses actively working at hospital centres in Spain.
Group C	Blood sample	Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain.
Group C	Data collection	Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain.
Group D	Blood sample	Subjects in this group will be all midwives actively working at hospital centres in Spain.
Group D	Data collection	Subjects in this group will be all midwives actively working at hospital centres in Spain.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years.	Day 0 of each subject at the time of enrollment.	By age and gender, by type of healthcare professional, by hospital department of the healthcare professional, duration of service and time spent with patients.
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.
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.
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Majadahonda, Spain