PertussisNCT01706224
Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals
An observational study of Pertussis, run by GlaxoSmithKline at 3 sites in Spain.
Trial summary
This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pertussis
- What is being tested?
- Blood sample and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 757 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare professionals actively working and involved with patient care in Spanish hospitals.
Who may be able to join
- 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.
Who cannot join
- Medical students working as healthcare professionals.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
L'Hospitalet de Llobregat, 08907
GSK Investigational Site
Majadahonda
About this study
Official title: Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain
This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain.
- Conditions
- Pertussis
- Being tested
- Blood sample, Data collection
- Keywords
- Pertussis antibodies, Bordetella pertussis, sero-prevalence, Healthcare professionals (HCP), Spain
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Samples will be tested to determine the presence of anti-pertussis antibodies.
Data collectionOther
Electronic Case Report Forms (eCRF)
Data collectionOther
Questionnaires, active questioning.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Subjects in this group will be all physicians actively working at hospital centres in Spain. Receives: Procedure: Blood sample; Other: Data collection | |
| Group B | Subjects in this group will be all nurses actively working at hospital centres in Spain. Receives: Procedure: Blood sample; Other: Data collection | |
| Group C | Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain. Receives: Procedure: Blood sample; Other: Data collection | |
| Group D | Subjects in this group will be all midwives actively working at hospital centres in Spain. Receives: Procedure: Blood sample; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels.
Measured: 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.
Measured: 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.
Measured: Day 0 of each subject at the time of enrollment.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 of each subject at the time of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706224
- Sponsor's protocol ID
- 115539
- Status last verified
- Jan 2014
- First submitted
- 27 Sep 2012
- Last updated
- 13 Jan 2014
- Results posted
- No
Publications
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.
PubMed 26718690
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain
- ClinicalTrials.gov ID
- NCT01706224
- Acronym / sponsor ID
- 115539
- Conditions
- Pertussis
- Keywords
- Pertussis antibodies, Bordetella pertussis, sero-prevalence, Healthcare professionals (HCP), Spain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Blood sample, Other: Data collectionSubjects in this group will be all physicians actively working at hospital centres in Spain. |
| Group B | – | Procedure: Blood sample, Other: Data collectionSubjects in this group will be all nurses actively working at hospital centres in Spain. |
| Group C | – | Procedure: Blood sample, Other: Data collectionSubjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain. |
| Group D | – | Procedure: Blood sample, Other: Data collectionSubjects in this group will be all midwives actively working at hospital centres in Spain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals actively working and involved with patient care in Spanish hospitals.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Medical students working as healthcare professionals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleSamples will be tested to determine the presence of anti-pertussis antibodies. | Procedure or surgery | Group A, Group B, Group C, Group D |
| Data collectionElectronic Case Report Forms (eCRF) | Other | Group A, Group B, Group C, Group D |
| Data collectionQuestionnaires, active questioning. | Other | Group A, Group B, Group C, Group D |
Primary outcome
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.
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.
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
- Derived from this study: PubMed 26718690Rodriguez 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.
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Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis, run by GlaxoSmithKline at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01706224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2014.