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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malaysia Group | Experimental | Malaysian adults aged >19 years with prolonged cough of 2 weeks or more. |
|
| Taiwan Group | Experimental | Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more. |
|
| Thailand Group | Experimental | Thailandese adults aged >19 years with prolonged cough of 2 weeks or more. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Procedure | 1 blood sample will be collected from each subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At time of blood sampling (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of clinical data collection prior to enrolment (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Kuala Lumpur | 59100 | Malaysia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26468043 | Derived | 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. |
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A total of 337 subjects were enrolled into this study, but only 312 had valid laboratory results. 2 subjects were excluded due to vulnerable conditions, 16 subjects were excluded due to protocol violation and 7 subjects were excluded due to vaccination with pertussis vaccines within 1 year before blood sample collection.
The duration of enrolment of all subjects was less than a year. Each subject attended one study visit at the time of enrolment, during which Quality of Life (QoL) and Health Economics (HE) questionnaires were administered and one blood sample was drawn.
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| ID | Title | Description |
|---|---|---|
| FG000 | Malaysia Group | Malaysian adults aged >19 years with prolonged cough of 2 weeks or more. |
| FG001 | Taiwan Group | Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more. |
| FG002 | Thailand Group | Thailandese adults aged >19 years with prolonged cough of 2 weeks or more. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Malaysia Group | Malaysian adults aged >19 years with prolonged cough of 2 weeks or more. |
| BG001 | Taiwan Group | Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The analysis was done on the According-to-Protocol (ATP) cohort which included all subjects with valid laboratory results. | Posted | Count of Participants | Participants | At time of blood sampling (Day 0) |
|
Serious Adverse Events were collected during the entire study period (at Day 0 from enrolment till completion of all study procedures).
Only Serious Adverse Events were monitored in this trial, Other (non-serious) Adverse Events were not collected as planned per protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Malaysia Group | Malaysian adults aged >19 years with prolonged cough of 2 weeks or more. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Data collection | Other | Quality of Life and HE questionnaires. |
|
| 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. | 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). | 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. | 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). | 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) | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | At time of questionnaire administration (Day 0) |
| Seremban |
| 70300 |
| Malaysia |
| GSK Investigational Site | Taichung | 40447 | Taiwan |
| GSK Investigational Site | Taoyuan | 333 | Taiwan |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| GSK Investigational Site | Songkhla | 90110 | Thailand |
| BG002 | Thailand Group | Thailandese adults aged >19 years with prolonged cough of 2 weeks or more. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Malaysian adults aged >19 years with prolonged cough of 2 weeks or more.
| OG001 | Taiwan Group | Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more. |
| OG002 | Thailand Group | Thailandese adults aged >19 years with prolonged cough of 2 weeks or more. |
|
|
| Secondary | 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. | The analysis was done on the ATP cohort for immunogenicity which included all subjects with valid laboratory results. For this outcome the subjects were grouped by their infection status: Subjects with Sero-confirmed infection and Subjects with Non-sero-confirmed infection. | Posted | Count of Participants | Participants | At time of clinical data collection prior to enrolment (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥ 62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Days | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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). | The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Count of Participants | Participants | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Visits to physician | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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). | The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Malaysian ringgit (RM) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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) | The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | New Taiwan dollar (NTD) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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). | The assessment was performed only on the Tailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Thai baht (BAHT) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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). | The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. One subject who reported 'out of pocket expenses' did not report 'Total medical cost'. | Posted | Mean | Standard Deviation | Malaysian ringgit (RM) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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). | The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | New Taiwan dollar (NTD) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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). | The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Thai baht (BAHT) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Malaysian ringgit (RM) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | New Taiwan dollar (NTD) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Thai baht (BAHT) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Malaysian ringgit (RM) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | New Taiwan dollar (NTD) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Thai baht (BAHT) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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 | The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. One subject who reported 'out of pocket expenses' did not report 'Total medical cost'. | Posted | Mean | Standard Deviation | Malaysia - Malaysian ringgit (RM) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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 | The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | New Taiwan dollar (NTD) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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 | The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Thai baht (BAHT) | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Hours | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Count of Participants | Participants | At time of questionnaire administration (Day 0) |
|
|
|
| Secondary | 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. | The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data. | Posted | Mean | Standard Deviation | Scores on a scale | At time of questionnaire administration (Day 0) |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 0 |
| EG001 | Taiwan Group | Taiwanese adults aged >19 years with prolonged cough of 2 weeks or more. | 0 | 89 | 0 | 89 | 0 | 0 |
| EG002 | Thailand Group | Thailandese adults aged >19 years with prolonged cough of 2 weeks or more. | 0 | 147 | 0 | 147 | 0 | 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Male |
|
| Paroxysm |
|
| Post tussive vomiting |
|
| Apnoea |
|
| Cyanosis |
|
| Coughing up phlegm |
|
| Sneezes |
|
| Wheezes |
|
| Cough at night |
|
| Episodes of being unable to stop coughing |
|
| Breathlessness /chest pain |
|
| Number of paid leave days due to cough |
|
| Number of unpaid leave days due to cough |
|
| Unknown/Not applicable |
|
| Average income loss/day >300 local currency units |
|
| Number of visits to Specialist clinic |
|
| Number of visits to the Emergency room |
|
| Total healthcare visits |
|
|
| Total cost for transportation |
|
| Amount for travel to Emergency room(s) |
|
| Total cost for transportation |
|
|
| Total cost for transportation |
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Total medical cost |
|
|
| Time spent for consultation with the specialist(s) |
|
| Time spent for treatment in the emergency room(s) |
|
| Total time spent to visit the healthcare resources |
|
| Self-Care |
|
| Usual Activities |
|
| Pain/Discomfort |
|
| Anxiety/Depression |
|