Trial Outcomes & Findings for Pertussis Infection in Adolescents and Adults With Prolonged Cough (NCT NCT01597687)

NCT ID: NCT01597687

Last Updated: 2019-08-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 337 participants
• Primary outcome timeframe: At time of blood sampling (Day 0)
• Results posted on: 2019-08-09

Participant Flow

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.

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.

Participant milestones

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Overall Study STARTED	76	89	147
Overall Study COMPLETED	76	89	147
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Malaysia Group n=76 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=89 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=147 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.	Total n=312 Participants Total of all reporting groups
Age, Continuous	48.08 Years STANDARD_DEVIATION 16.76 • n=76 Participants	39.20 Years STANDARD_DEVIATION 12.29 • n=89 Participants	42.66 Years STANDARD_DEVIATION 15.73 • n=147 Participants	42.99 Years STANDARD_DEVIATION 15.40 • n=312 Participants
Sex: Female, Male Female	49 Participants n=76 Participants	60 Participants n=89 Participants	101 Participants n=147 Participants	210 Participants n=312 Participants
Sex: Female, Male Male	27 Participants n=76 Participants	29 Participants n=89 Participants	46 Participants n=147 Participants	102 Participants n=312 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At time of blood sampling (Day 0)

Population: The analysis was done on the According-to-Protocol (ATP) cohort which included all subjects with valid laboratory results.

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

Outcome measures

Measure	Malaysia Group n=76 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=89 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=147 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Serological Evidence of Pertussis Infection Seronegative	50 Participants	74 Participants	84 Participants
Serological Evidence of Pertussis Infection Seropositive	26 Participants	15 Participants	63 Participants
Serological Evidence of Pertussis Infection Sero-confirmed infection	6 Participants	1 Participants	9 Participants
Serological Evidence of Pertussis Infection Active infection 1	1 Participants	0 Participants	3 Participants
Serological Evidence of Pertussis Infection Active infection 2	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: At time of clinical data collection prior to enrolment (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group n=16 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=296 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Number of Participants With Specific Clinical Features Whoop · Yes	2 Participants	18 Participants	—
Number of Participants With Specific Clinical Features Whoop · No	14 Participants	278 Participants	—
Number of Participants With Specific Clinical Features Paroxysm · Yes	12 Participants	143 Participants	—
Number of Participants With Specific Clinical Features Paroxysm · No	4 Participants	153 Participants	—
Number of Participants With Specific Clinical Features Post tussive vomiting · Yes	6 Participants	72 Participants	—
Number of Participants With Specific Clinical Features Post tussive vomiting · No	10 Participants	224 Participants	—
Number of Participants With Specific Clinical Features Apnoea · Yes	0 Participants	3 Participants	—
Number of Participants With Specific Clinical Features Apnoea · No	16 Participants	293 Participants	—
Number of Participants With Specific Clinical Features Cyanosis · Yes	0 Participants	0 Participants	—
Number of Participants With Specific Clinical Features Cyanosis · No	16 Participants	296 Participants	—
Number of Participants With Specific Clinical Features Coughing up phlegm · Yes	6 Participants	180 Participants	—
Number of Participants With Specific Clinical Features Coughing up phlegm · No	10 Participants	116 Participants	—
Number of Participants With Specific Clinical Features Sneezes · Yes	6 Participants	111 Participants	—
Number of Participants With Specific Clinical Features Sneezes · No	10 Participants	185 Participants	—
Number of Participants With Specific Clinical Features Wheezes · Yes	3 Participants	34 Participants	—
Number of Participants With Specific Clinical Features Wheezes · No	13 Participants	262 Participants	—
Number of Participants With Specific Clinical Features Cough at night · Yes	11 Participants	211 Participants	—
Number of Participants With Specific Clinical Features Cough at night · No	5 Participants	85 Participants	—
Number of Participants With Specific Clinical Features Episodes of being unable to stop coughing · Yes	7 Participants	140 Participants	—
Number of Participants With Specific Clinical Features Episodes of being unable to stop coughing · No	9 Participants	156 Participants	—
Number of Participants With Specific Clinical Features Breathlessness /chest pain · Yes	10 Participants	106 Participants	—
Number of Participants With Specific Clinical Features Breathlessness /chest pain · No	6 Participants	190 Participants	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

Absenteeism was assessed as the mean number of days missed from work due to cough.

Outcome measures

Measure	Malaysia Group n=4 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough Number of days absent from work due to cough	7.75 Days Standard Deviation 14.84	0.00 Days Standard Deviation NA No absences from work due to cough were reported, hence Standard Deviation cannot be computed.	0.22 Days Standard Deviation 0.67
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough Number of paid leave days due to cough	0.25 Days Standard Deviation 0.50	0.00 Days Standard Deviation NA No absences from work due to cough were reported, hence Standard Deviation cannot be computed.	0.22 Days Standard Deviation 0.67
Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough Number of unpaid leave days due to cough	7.50 Days Standard Deviation 15.00	0.00 Days Standard Deviation NA No absences from work due to cough were reported, hence Standard Deviation cannot be computed.	0.00 Days Standard Deviation NA No unpaid leave days due to cough were reported, hence Standard Deviation cannot be computed.

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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).

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
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 · Yes	1 Participants	0 Participants	0 Participants
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 · No	3 Participants	1 Participants	9 Participants
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 · Unknown/Not applicable	2 Participants	0 Participants	0 Participants
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work Average income loss/day >300 local currency units · Yes	1 Participants	0 Participants	0 Participants
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work Average income loss/day >300 local currency units · No	0 Participants	0 Participants	0 Participants
Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work Average income loss/day >300 local currency units · Unknown/Not applicable	5 Participants	1 Participants	9 Participants

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

Healthcare resource utilization was assessed by the mean number of visits to any type of physicians.

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources Number of visits to GP/ family physician clinic	3.17 Visits to physician Standard Deviation 2.40	0.00 Visits to physician Standard Deviation NA No visits to GP/ family physician clinic were reported, hence Standard Deviation could not be computed.	1.00 Visits to physician Standard Deviation 1.00
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources Number of visits to Specialist clinic	0.33 Visits to physician Standard Deviation 0.52	8.00 Visits to physician Standard Deviation NA Only one participant reported visits to Specialist clinic. Standard Deviation cannot be computed on a single value.	1.00 Visits to physician Standard Deviation 0.50
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources Number of visits to the Emergency room	0.50 Visits to physician Standard Deviation 0.84	1.00 Visits to physician Standard Deviation NA Only one participant reported visits to the Emergency Room. Standard Deviation cannot be computed on a single value.	0.00 Visits to physician Standard Deviation NA No visits to the Emergency Room were reported, hence Standard Deviation could not be computed.
Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources Total healthcare visits	4.00 Visits to physician Standard Deviation 3.03	9.00 Visits to physician Standard Deviation NA Only one participant reported healthcare visits. Standard Deviation cannot be computed on a single value.	2.00 Visits to physician Standard Deviation 1.12

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia Amount for travel to consultation with GP(s)	43.83 Malaysian ringgit (RM) Standard Deviation 54.77	—	—
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia Amount for travel to consultation with specialist	2.50 Malaysian ringgit (RM) Standard Deviation 4.18	—	—
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia Amount for travel to Emergency room(s)	9.17 Malaysian ringgit (RM) Standard Deviation 16.25	—	—
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia Total cost for transportation	55.50 Malaysian ringgit (RM) Standard Deviation 63.71	—	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

The travel costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD)

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan Amount for travel to consultation with GP(s)	—	0.00 New Taiwan dollar (NTD) Standard Deviation NA No visits to GP/ family physician clinic were reported, hence Standard Deviation could not be computed.	—
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan Amount for travel to consultation with specialist	—	2400.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported visits to Specialist clinic. Standard Deviation cannot be computed on a single value.	—
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan Amount for travel to Emergency room(s)	—	300.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported visits to the Emergency Room. Standard Deviation cannot be computed on a single value.	—
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan Total cost for transportation	—	2700.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported healthcare visits. Standard Deviation cannot be computed on a single value.	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

The travel costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT).

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand Amount for travel to consultation with GP(s)	—	—	1133.30 Thai baht (BAHT) Standard Deviation 1450.90
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand Amount for travel to consultation with specialist	—	—	668.89 Thai baht (BAHT) Standard Deviation 709.09
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand Amount for travel to Emergency room(s)	—	—	0.00 Thai baht (BAHT) Standard Deviation NA No visits to the Emergency Room were reported, hence Standard Deviation could not be computed.
Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand Total cost for transportation	—	—	1802.20 Thai baht (BAHT) Standard Deviation 1819.20

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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'.

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).

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia Out of Pocket expense	47.50 Malaysian ringgit (RM) Standard Deviation 9.57	—	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia Total medical cost	43.33 Malaysian ringgit (RM) Standard Deviation 5.77	—	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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).

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan Out of Pocket expense	—	0.00 New Taiwan dollar (NTD) Standard Deviation NA No visits to GP/ family physician clinic were reported, hence Standard Deviation could not be computed.	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan Total medical cost	—	0.00 New Taiwan dollar (NTD) Standard Deviation NA No visits to GP/ family physician clinic were reported, hence Standard Deviation could not be computed.	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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).

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand Out of Pocket expense	—	—	1114.30 Thai baht (BAHT) Standard Deviation 1665.80
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand Total medical cost	—	—	1114.30 Thai baht (BAHT) Standard Deviation 1665.80

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia Out of Pocket expense	0.00 Malaysian ringgit (RM) Standard Deviation NA None of the participants with available data reported any expenses for visits to specialist clinics, hence Standard Deviation could not be computed.	—	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia Total medical cost	0.00 Malaysian ringgit (RM) Standard Deviation NA None of the participants with available data reported any expenses for visits to specialist clinics, hence Standard Deviation could not be computed.	—	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan Out of Pocket expense	—	1700.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported expenses for visiting specialist clinics. Standard Deviation cannot be computed on a single value.	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan Total medical cost	—	1700.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported expenses for visiting specialist clinics. Standard Deviation cannot be computed on a single value.	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand Out of Pocket expense	—	—	645.71 Thai baht (BAHT) Standard Deviation 711.87
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand Total medical cost	—	—	645.71 Thai baht (BAHT) Standard Deviation 711.87

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia Out of Pocket expense	0.00 Malaysian ringgit (RM) Standard Deviation NA None of the participants with available data reported any expenses for Emergency Room visits, hence Standard Deviation could not be computed.	—	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia Total medical cost	0.00 Malaysian ringgit (RM) Standard Deviation NA None of the participants with available data reported any expenses for Emergency Room visits, hence Standard Deviation could not be computed.	—	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan Out of Pocket expense	—	750.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported any expenses for Emergency Room visits. Standard Deviation cannot be computed for a single value.	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan Total medical cost	—	750.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported any expenses for Emergency Room visits. Standard Deviation cannot be computed for a single value.	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand Out of Pocket expense	—	—	0.00 Thai baht (BAHT) Standard Deviation NA No Emergency Room visits were reported, hence Standard Deviation could not be computed.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand Total medical cost	—	—	0.00 Thai baht (BAHT) Standard Deviation NA No Emergency Room visits were reported, hence Standard Deviation could not be computed.

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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'.

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

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia Out of Pocket expense	47.50 Malaysia - Malaysian ringgit (RM) Standard Deviation 9.57	—	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia Total medical cost	43.33 Malaysia - Malaysian ringgit (RM) Standard Deviation 5.77	—	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan Out of Pocket expense	—	2450.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported any expenses for visiting healthcare resources. Standard Deviation cannot be computed on a single value.	—
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan Total medical cost	—	2450.00 New Taiwan dollar (NTD) Standard Deviation NA Only one participant reported any expenses for visiting healthcare resources. Standard Deviation cannot be computed on a single value.	—

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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

Outcome measures

Measure	Malaysia Group Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand Out of Pocket expense	—	—	1760.00 Thai baht (BAHT) Standard Deviation 1978.00
Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand Total medical cost	—	—	1760.00 Thai baht (BAHT) Standard Deviation 1978.00

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General Total time spent to visit the healthcare resources	7.88 Hours Standard Deviation 10.52	23.00 Hours Standard Deviation NA Only one participant reported time spent at any healthcare resources. Standard Deviation cannot be computed on a single value.	5.25 Hours Standard Deviation 4.88
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General Time spent for consultation with the GP(s)	6.38 Hours Standard Deviation 8.74	0.00 Hours Standard Deviation NA No consultations with the GP were reported, hence Standard Deviation could not be computed.	2.28 Hours Standard Deviation 2.97
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General Time spent for consultation with the specialist(s)	0.33 Hours Standard Deviation 0.52	20.00 Hours Standard Deviation NA Only one participant reported any consultation with the Specialist. Standard Deviation cannot be computed on a single value.	2.97 Hours Standard Deviation 3.13
Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General Time spent for treatment in the emergency room(s)	1.17 Hours Standard Deviation 1.83	3.00 Hours Standard Deviation NA Only one participant reported time spent at the Emergency Room. Standard Deviation cannot be computed on a single value.	0.00 Hours Standard Deviation NA No Emergency Room visitis were reported, hence Standard Deviation could not be computed.

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Mobility · No problems	6 Participants	1 Participants	7 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Mobility · With problems	0 Participants	0 Participants	2 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Self-Care · No problems	6 Participants	1 Participants	9 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Self-Care · With problems	0 Participants	0 Participants	0 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Usual Activities · No problems	4 Participants	0 Participants	6 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Usual Activities · With problems	2 Participants	1 Participants	3 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Pain/Discomfort · No problems	4 Participants	0 Participants	6 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Pain/Discomfort · With problems	2 Participants	1 Participants	3 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Anxiety/Depression · No problems	3 Participants	0 Participants	6 Participants
Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics Anxiety/Depression · With problems	3 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: At time of questionnaire administration (Day 0)

Population: 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.

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.

Outcome measures

Measure	Malaysia Group n=6 Participants Malaysian adults aged \>19 years with prolonged cough of 2 weeks or more.	Taiwan Group n=1 Participants Taiwanese adults aged \>19 years with prolonged cough of 2 weeks or more.	Thailand Group n=9 Participants Thailandese adults aged \>19 years with prolonged cough of 2 weeks or more.
Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score	0.84 Scores on a scale Standard Deviation 0.18	0.66 Scores on a scale Standard Deviation NA Standard Deviation cannot be computed for a single value.	0.75 Scores on a scale Standard Deviation 0.21

Adverse Events

Malaysia Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Taiwan Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Thailand Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER