PertussisNCT01597687
Pertussis Infection in Adolescents and Adults With Prolonged Cough
A study testing Blood collection and Data collection in people with Pertussis, run by GlaxoSmithKline at 7 sites in 3 countries.
Trial summary
This study aims to determine the burden of pertussis infection among adolescents and adults with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and Thailand. This study also aims to assess the health economic (HE) impact of pertussis. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pertussis
- What is being tested?
- Blood collection and Data collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 20 Jun 2012to 2 May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adolescents aged 13-18 years or adults aged >18years.
- Presenting with prolonged cough of 2 weeks (14 days) or more.
- Subjects who the investigator believes that they/ their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/ from the parent(s)/LAR of the subject. If the subject below the age of consent is legally eligible, his/her signature on the informed assent form should be obtained.
Who cannot join
- Child in care.
- Subjects with known chronic cough-causing disease and immunodeficiency.
- Subjects treated with angiotensin-converting enzyme inhibitors (ACEI), within the past 4 weeks (28 days).
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Thailand3 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Songkhla, 90110
Malaysia2 sites
GSK Investigational Site
Kuala Lumpur, 59100
GSK Investigational Site
Seremban, 70300
Taiwan2 sites
GSK Investigational Site
Taichung, 40447
GSK Investigational Site
Taoyuan, 333
About this study
Official title: Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough
This study aims to determine the burden of pertussis infection among adolescents and adults with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and Thailand. This study also aims to assess the health economic (HE) impact of pertussis.
Read the detailed description
Data from this cross-sectional study will be useful in reviewing the need for introduction of booster doses of pertussis vaccines in adolescent and adult population in Malaysia, Philippines, Taiwan and Thailand.
This study will enrol patients with prolonged cough of 2 weeks or more and detect pertussis with serological tests in order to estimate the prevalence of pertussis infection among such patients. No vaccine will be administered during this study.
- Conditions
- Pertussis
- Being tested
- Blood collection, Data collection
- Keywords
- pertussis infection, Prevalence, health economic burden, prolonged cough
- 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 collectionProcedure or surgery
1 blood sample will be collected from each subject.
Data collectionOther
Quality of Life and HE questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Malaysia Group | Experimental | Malaysian adults aged >19 years with prolonged cough of 2 weeks or more. Receives: Procedure: Blood collection; Other: Data collection |
| Taiwan Group | Experimental | Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more. Receives: Procedure: Blood collection; Other: Data collection |
| Thailand Group | Experimental | Thailandese adults aged >19 years with prolonged cough of 2 weeks or more. Receives: Procedure: Blood collection; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological Evidence of Pertussis Infection
Serological evidence of pertussis infection was defined as anti-pertussis toxin (PT) immunoglobulin G (IgG) level indicative of active or recent infection. The parameters presented were defined as follows: Seropositive = Subjects with anti-PT IgG ELISA levels ≥10 IU/ml , Seronegative = Subjects with anti-PT IgG ELISA levels < 10 IU/ml , Sero-confirmed infection = Subjects with anti-PT IgG ELISA levels ≥62.5 IU/ml , Active infection 1= Anti-PT IgG ELISA levels ≥ 100 IU/ml indicative of active or recent infection, Active infection 2 = Anti-PT IgG ELISA levels ≥ 125 IU/ml indicative of active or recent infection
Measured: At time of blood sampling (Day 0)
Secondary outcomes (22)
Number of Participants With Specific Clinical Features
Clinical features assessed included paroxysm, whoop, night cough, cyanosis, fever post-tussive vomiting, apnoea, cyanosis, coughing up phlegm, sneezes, wheezes, episodes of being unable to stop coughing and breathlessness/chest pain.
Measured: At time of clinical data collection prior to enrolment (Day 0)
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough
Absenteeism was assessed as the mean number of days missed from work due to cough.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work
Loss of income due to missing work for sero-confirmed subjects was measured in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM), Taiwan - New Taiwan dollar (NTD), Thailand - Thai baht (BAHT).
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources
Healthcare resource utilization was assessed by the mean number of visits to any type of physicians.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia
The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan
The travel costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD)
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand
The travel costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT).
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia
The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan
The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand
The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general
Measured: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General
Total amount of time spent on seeing the doctor(s) which includes the return trip and the overall time spent at clinic(s)/hospital(s) for waiting, consultation, tests, pharmacy etc.
Measured: At time of questionnaire administration (Day 0)
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics
Health-related quality of life of pertussis patients was assessed using the EQ-5D Questionnaire. The EQ-5D is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with 3 levels of severity within each dimension. The EQ-5D levels were further dichotomised into "no problems" (level 1) and "with problems" (level 2 \& 3). The number of participants within these 2 levels are reported.
Measured: At time of questionnaire administration (Day 0)
Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score
Health-related quality of life of pertussis patients was assessed using the EQ-5D Questionnaire. The EQ-5D is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with 3 levels of severity within each dimension. Average of EQ-5D index score (ranging from 0 to 1; 0 being death and 1 being in perfect health) across sero-confirmed participants was reported.
Measured: At time of questionnaire administration (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study start20 Jun 2012
- Primary completion2 May 2013
- Study completion2 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 337 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
- NCT01597687
- Sponsor's protocol ID
- 115741
- Status last verified
- Jun 2019
- First submitted
- 3 May 2012
- Last updated
- 9 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Koh MT, Liu CS, Chiu CH, Boonsawat W, Watanaveeradej V, Abdullah N, Zhang X, Devadiga R, Chen J. Under-recognized pertussis in adults from Asian countries: a cross-sectional seroprevalence study in Malaysia, Taiwan and Thailand. Epidemiol Infect. 2016 Apr;144(6):1192-200. doi: 10.1017/S0950268815002393. Epub 2015 Oct 15.
PubMed 26468043
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bordetella Pertussis Infection Among Adolescents and Adults With Prolonged Cough
- ClinicalTrials.gov ID
- NCT01597687
- Acronym / sponsor ID
- 115741
- Conditions
- Pertussis
- Keywords
- pertussis infection, Prevalence, health economic burden, prolonged cough
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 2 May 2013 (actual)
- Study completion
- 2 May 2013 (actual)
- First posted
- 14 May 2012 (estimated)
- Results
- Posted 9 Aug 2019
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 burden of pertussis infection among adolescents and adults with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and Thailand. This study also aims to assess the health economic (HE) impact of pertussis.
Detailed description
Data from this cross-sectional study will be useful in reviewing the need for introduction of booster doses of pertussis vaccines in adolescent and adult population in Malaysia, Philippines, Taiwan and Thailand.
This study will enrol patients with prolonged cough of 2 weeks or more and detect pertussis with serological tests in order to estimate the prevalence of pertussis infection among such patients. No vaccine will be administered during this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Malaysia Group | Experimental | Procedure: Blood collection, Other: Data collectionMalaysian adults aged >19 years with prolonged cough of 2 weeks or more. |
| Taiwan Group | Experimental | Procedure: Blood collection, Other: Data collectionTaiwanese adults aged >19 years with prolonged cough of 2 weeks or more. |
| Thailand Group | Experimental | Procedure: Blood collection, Other: Data collectionThailandese adults aged >19 years with prolonged cough of 2 weeks or more. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adolescents aged 13-18 years or adults aged >18years.
- Presenting with prolonged cough of 2 weeks (14 days) or more.
- Subjects who the investigator believes that they/ their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/ from the parent(s)/LAR of the subject. If the subject below the age of consent is legally eligible, his/her signature on the informed assent form should be obtained.
Key exclusion criteria (3 listed)
- Child in care.
- Subjects with known chronic cough-causing disease and immunodeficiency.
- Subjects treated with angiotensin-converting enzyme inhibitors (ACEI), within the past 4 weeks (28 days).
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 collection1 blood sample will be collected from each subject. | Procedure or surgery | Malaysia Group, Taiwan Group, Thailand Group |
| Data collectionQuality of Life and HE questionnaires. | Other | Malaysia Group, Taiwan Group, Thailand Group |
Primary outcome
Serological Evidence of Pertussis Infection
Time frame: At time of blood sampling (Day 0)
Serological evidence of pertussis infection was defined as anti-pertussis toxin (PT) immunoglobulin G (IgG) level indicative of active or recent infection. The parameters presented were defined as follows: Seropositive = Subjects with anti-PT IgG ELISA levels ≥10 IU/ml , Seronegative = Subjects with anti-PT IgG ELISA levels < 10 IU/ml , Sero-confirmed infection = Subjects with anti-PT IgG ELISA levels ≥62.5 IU/ml , Active infection 1= Anti-PT IgG ELISA levels ≥ 100 IU/ml indicative of active or recent infection, Active infection 2 = Anti-PT IgG ELISA levels ≥ 125 IU/ml indicative of active or recent infection
22 secondary outcomes
Number of Participants With Specific Clinical Features
Time frame: At time of clinical data collection prior to enrolment (Day 0)
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand
Time frame: At time of questionnaire administration (Day 0)
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General
Time frame: At time of questionnaire administration (Day 0)
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics
Time frame: At time of questionnaire administration (Day 0)
Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score
Time frame: At time of questionnaire administration (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26468043Koh MT, Liu CS, Chiu CH, Boonsawat W, Watanaveeradej V, Abdullah N, Zhang X, Devadiga R, Chen J. Under-recognized pertussis in adults from Asian countries: a cross-sectional seroprevalence study in Malaysia, Taiwan and Thailand. Epidemiol Infect. 2016 Apr;144(6):1192-200. doi: 10.1017/S0950268815002393. Epub 2015 Oct 15.
- Individual participant dataSharing planned: No
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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
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection and Data collection in people with Pertussis, run by GlaxoSmithKline at 7 sites in 3 countries.
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 4 inclusion and 3 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 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Thailand, Malaysia, Taiwan. 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?
Yes. Results are posted in the registry (first posted 9 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serological Evidence of Pertussis Infection (time frame: At time of blood sampling (Day 0)). 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 NCT01597687, 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 9 Aug 2019.