Trial Outcomes & Findings for This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia (NCT NCT02766088)
NCT ID: NCT02766088
Last Updated: 2024-03-15
Results Overview
Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
TERMINATED
NA
1750 participants
From Day 0 to Month 24 (study end)
2024-03-15
Participant Flow
In December 2017, GSK decided to deprioritize the development of the dengue purified inactivated vaccine (DPIV) candidate. This decision was made due to the significant scientific challenges of dengue vaccine development. Hence, only 2 sites participated to the study, 1 in Mexico and 1 in Philippines.
Participant milestones
| Measure |
Total Group
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Overall Study
STARTED
|
850
|
|
Overall Study
COMPLETED
|
344
|
|
Overall Study
NOT COMPLETED
|
506
|
Reasons for withdrawal
| Measure |
Total Group
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Overall Study
Sponsor study termination
|
498
|
|
Overall Study
Migrated/moved from the study area
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Other
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Group
n=850 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Age, Continuous
|
17.4 years
STANDARD_DEVIATION 13.38 • n=850 Participants
|
|
Sex: Female, Male
Female
|
456 Participants
n=850 Participants
|
|
Sex: Female, Male
Male
|
394 Participants
n=850 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.
Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
Outcome measures
| Measure |
Total Group
n=850 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
Mexico
|
1.1 Percentage of subjects
Interval 0.4 to 3.0
|
|
Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
Philippines
|
0.8 Percentage of subjects
Interval 0.3 to 2.1
|
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: No data was collected by DENV-type due to the low number of cases reported, therefore no analysis could be performed.
Dengue Virus (DENV)-Type 1, 2 3 or 4 Ribonucleid acid would have been considered for this analysis but it was not performed due to the low number of cases reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.
Incidence proportion of virologically confirmed symptomatic dengue infection was estimated from GEE logistic regression model taking the clustering effect into account. The 95% confidence interval was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Virologically confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR or non-structural protein 1 (NS1). See SDC definition in outcome 5.
Outcome measures
| Measure |
Total Group
n=350 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico
|
1.4 Proportion of subjects
Interval 0.5 to 3.8
|
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects from the Philippines, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.
Incidence percentage of virologically confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
Outcome measures
| Measure |
Total Group
n=500 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.
|
0.8 Percentage of subjects
Interval 0.3 to 2.1
|
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.
Incidence proportion of probable confirmed symptomatic dengue infection was estimated from GEE model with clustering effect. Clusters were households for analysis by study site and study sites for analysis on overall study sites. A probable confirmed dengue infection is an SDC with DENV RT-qPCR negative or not performed (late presenter), and DENV NS1 negative or undetermined (early or late presenter), and Anti-DENV Immunoglobulin type M (IgM) positive with a rapid immunochromatographic (ICT) assay or an Enzyme-linked Immunosorbent Assay (ELISA) assay, or Anti-DENV IgG positive (rapid ICT assay or 'capture ELISA' assay). SDC defined as acute febrile illness measured as greater or equal to 38.0°C or recent history of febrile illness (onset in the past 8 days) reported for at least 2 consecutive days (duration of approximately 36-48 hours) and \< 7 days duration, which might be accompanied by other dengue symptoms or signs with no defined focus or obvious reason unrelated to dengue.
Outcome measures
| Measure |
Total Group
n=850 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.
|
0 Proportion of subjects
The 95% CI was not calculated as no cases reported.
|
SECONDARY outcome
Timeframe: At Day 0Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.
The proportion of subjects with Dengue Virus antibody IgG positive result (ELISA) was estimated from GEE model with clustering effect. The 95% CI was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately, as there were no probable cases reported in the study.
Outcome measures
| Measure |
Total Group
n=782 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Mexico- 6 months -12 months
|
0 Proportion of subjects
The 95% CI was not calculated as no cases reported.
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Mexico- 5-8 years
|
11.8 Proportion of subjects
Interval 4.5 to 27.5
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Mexico- 9-17 years
|
16.6 Proportion of subjects
Interval 9.8 to 26.6
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Mexico- 18-50 years
|
27.2 Proportion of subjects
Interval 19.8 to 36.2
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Philippines- 1-4 years
|
31.2 Proportion of subjects
Interval 21.7 to 42.7
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Philippines- 5-8 years
|
51.5 Proportion of subjects
Interval 40.8 to 62.0
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Philippines- 9-17 years
|
92.0 Proportion of subjects
Interval 86.4 to 95.4
|
|
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Philippines- 18-50 years
|
99.3 Proportion of subjects
Interval 95.4 to 99.9
|
SECONDARY outcome
Timeframe: At Day 0Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects from Mexico (1-4 years age) and the Philippines (6-12 months), i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.
The percentage of subjects with Dengue Virus antibody IgG positive result (ELISA) was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately as there were no probable cases reported in the study.
Outcome measures
| Measure |
Total Group
n=59 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Mexico- 1-4 years
|
6.4 Percentage of subjects
Interval 2.1 to 18.0
|
|
Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
Philippines- 6 months -12 months
|
8.3 Percentage of subjects
Interval 1.2 to 41.3
|
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol, for whom data of at least one follow-up contact were available and who were defined as suspected dengue cases.
The following characteristics were summarized for each category of dengue cases (Virologically confirmed, probable, other SDC): Temperature at first visit: \<37.5, ≥37.5, \>38, \>38.5, \>39 °C and Clinical symptoms at onset, from first and returned visits. The results are presented for the virologically confirmed cases (VDC) and the other SDC (oSDC), no probable cases being reported in the study.
Outcome measures
| Measure |
Total Group
n=27 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature <37.5 °C VDC
|
5 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one main sign oSDC
|
18 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Abdominal pain oSDC
|
8 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Urinary tract bleeding oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature ≥37.5 °C VDC
|
4 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature >38.0 °C VDC
|
4 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature >38.5 °C VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature >39.0 °C VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one main sign VDC
|
9 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Fever VDC
|
9 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Headache VDC
|
7 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Retroorbital pain [eye pain] VDC
|
6 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Myalgia VDC
|
5 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Join pain VDC
|
3 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Chills VDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Rash VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Itching VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one digestive symptom VDC
|
5 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Abdominal pain VDC
|
5 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Nausea or vomiting VDC
|
4 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Diarrhea VDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one respiratory symptom VDC
|
5 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Cough VDC
|
4 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Nasal Congestion VDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Sore throat VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Dyspnea VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one hemorrhagic manifestation VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Petechia VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Purpura/ecchymosis VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Hematemesis [vomiting of blood] VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Melena/hematochezia [blood in stool] VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Gingival bleeding VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Epistaxis VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Urinary tract bleeding VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Unusual vaginal bleeding VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one other signs VDC
|
6 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Pallor or cool skin VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Conjunctivis VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Jaundice VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Convulsion or coma VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Lethargy or restlessness VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Clinical fluid accumulation VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Dizziness VDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Thoracic pain VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Other VDC
|
6 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature <37.5 °C oSDC
|
15 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature ≥37.5 °C oSDC
|
3 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature >38.0 °C oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature >38.5 °C oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Temperature >39.0 °C oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Fever oSDC
|
18 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Headache oSDC
|
15 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Retroorbital pain [eye pain] oSDC
|
9 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Myalgia oSDC
|
11 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Join pain oSDC
|
8 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Chills oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Rash oSDC
|
4 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Itching oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one digestive symptom oSDC
|
12 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Nausea or vomiting oSDC
|
11 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Diarrhea oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one respiratory symptom oSDC
|
11 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Cough oSDC
|
8 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Nasal Congestion oSDC
|
6 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Sore throat oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Dyspnea oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one hemorrhagic manifestation oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Petechia oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Purpura/ecchymosis oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Hematemesis [vomiting of blood] oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Melena/hematochezia [blood in stool] oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Gingival bleeding oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Epistaxis oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Unusual vaginal bleeding oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
At least one other signs oSDC
|
10 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Pallor or cool skin oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Conjunctivis oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Jaundice oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Convulsion or coma oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Lethargy or restlessness oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Clinical fluid accumulation oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Dizziness oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Thoracic pain oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
Other oSDC
|
7 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol, for whom data of at least one follow-up contact were available and who were defined as suspected dengue cases.
The clinical classification of the suspected dengue cases were distributed among following categories: Subject hospitalized during suspected dengue episode; OR At least 1 WHO 2009 warning signs: i.e. Abdominal pain or tenderness, Persistent vomiting, Clinical fluid accumulation, Mucosal bleed, Liver enlargement, Increase in HCT concurrent with rapid decrease in platelet count, Lethargy and restlessness; OR At least 1 WHO 2009 criteria for severe dengue: i.e. Severe Plasma Leakage leading to Shock, Fluid accumulation with respiratory distress, Severe Bleeding, Severe organ involvement; Liver: Aspartate transaminase or Alanine transferase ≥ 1000 International Unit/Liter, Central nervous system: impaired consciousness, Failure of heart and other organs; OR Most likely diagnosis for an episode of defined illnesses \[investigator opinion\]. The following characteristics were summarized for Virologically confirmed cases (VDC) and other SDC (oSDC), no probable cases being reported.
Outcome measures
| Measure |
Total Group
n=27 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Subject hospitalized oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
At least 1 WHO 2009 warning signs oSDC
|
1 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
At least 1 WHO 2009 severe dengue criteria oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Dengue oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Chikungunya oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Influenza oSDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Malaria oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Leptospirosis oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Rota/enteric infection oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: other infection oSDC
|
18 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: non-infectious disease oSDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Subject hospitalized VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
At least 1 WHO 2009 warning signs VDC
|
5 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
At least 1 WHO 2009 severe dengue criteria VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Dengue VDC
|
7 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Chikungunya VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Influenza VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Malaria VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Leptospirosis VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: Rota/enteric infection VDC
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: other infection disease VDC
|
2 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria Characteristics
Most likely diagnosis: non-infectious disease VDC
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Month 24 (study end)Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject..
Outcome measures
| Measure |
Total Group
n=850 Participants
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches were considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure
|
0 Participants
|
Adverse Events
Total Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
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