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

Purpose

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

Condition	Intervention
Diphtheria-Tetanus-acellular Pertussis Vaccines	Procedure: Blood sample Other: Data collection

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]
Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seropositivity status. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]
Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seronegativity status. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]
Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by previous history of pertussis. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]
Description of the knowledge and beliefs about whooping cough and vaccination against pertussis among healthcare professionals. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]
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. [ Time Frame: Day 0 of each subject at the time of enrollment. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Blood

Estimated Enrollment:	756
Study Start Date:	November 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group A Subjects in this group will be all physicians actively working at hospital centres in Spain.	Procedure: Blood sample Samples will be tested to determine the presence of anti-pertussis antibodies. Other: Data collection Electronic Case Report Forms (eCRF) Other: Data collection Questionnaires, active questioning.
Group B Subjects in this group will be all nurses actively working at hospital centres in Spain.	Procedure: Blood sample Samples will be tested to determine the presence of anti-pertussis antibodies. Other: Data collection Electronic Case Report Forms (eCRF) Other: Data collection Questionnaires, active questioning.
Group C Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain.	Procedure: Blood sample Samples will be tested to determine the presence of anti-pertussis antibodies. Other: Data collection Electronic Case Report Forms (eCRF) Other: Data collection Questionnaires, active questioning.
Group D Subjects in this group will be all midwives actively working at hospital centres in Spain.	Procedure: Blood sample Samples will be tested to determine the presence of anti-pertussis antibodies. Other: Data collection Electronic Case Report Forms (eCRF) Other: Data collection Questionnaires, active questioning.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthcare professionals actively working and involved with patient care in Spanish hospitals.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706224

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Locations

Spain
GSK Investigational Site	Completed
Hospitalet de Llobregat, Spain, 08907
GSK Investigational Site	Recruiting
La Coruña, Spain, 15006
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com
GSK Investigational Site	Completed
Majadahonda, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01706224 History of Changes
Other Study ID Numbers:	115539
Study First Received:	September 27, 2012
Last Updated:	May 2, 2013
Health Authority:	Spain: Agencia Española del Medicamento y Productos Sanitarios

Keywords provided by GlaxoSmithKline:

Pertussis antibodies
Bordetella pertussis
sero-prevalence
Healthcare professionals (HCP)
Spain

Additional relevant MeSH terms:

Diphtheria
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections

Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013