Last updated: 11/03/2018 18:14:26
Sero-prevalence of anti-pertussis antibodies and disease awareness among Spanish healthcare professionals
GSK study ID
115539
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Sero-prevalence of pertussis antibodies and disease awareness among healthcare professionals in Spain
Trial description: This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
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.
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:
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.
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.
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.
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.
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.
Interventions:
Procedure/surgery: Blood sample
Other: Data collection
Enrollment:
757
Observational study model:
Cohort
Primary completion date:
2013-28-05
Time perspective:
Cross-Sectional
Clinical publications:
Not applicable
Medical condition
Pertussis
Product
GSK2647153A, SB263855
Collaborators
Not applicable
Study date(s)
November 2012 to May 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Written informed consent obtained from the subject.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Medical students working as healthcare professionals.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Written informed consent obtained from the subject.
Exclusion criteria:
Medical students working as healthcare professionals.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2013-28-05
Actual study completion date
2013-28-05
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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