Trial Outcomes & Findings for An Epidemiological Surveillance Study to Evaluate the Incidence of Dengue in Brazil (NCT NCT01751139)
NCT ID: NCT01751139
Last Updated: 2020-04-27
Results Overview
Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3300 participants
Primary outcome timeframe
At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years
Results posted on
2020-04-27
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.
Participant milestones
| Measure |
Total Group
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Overall Study
STARTED
|
3300
|
|
Overall Study
COMPLETED
|
1033
|
|
Overall Study
NOT COMPLETED
|
2267
|
Reasons for withdrawal
| Measure |
Total Group
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Overall Study
Other
|
135
|
|
Overall Study
Sponsor study termination
|
1609
|
|
Overall Study
Lost to Follow-up
|
240
|
|
Overall Study
Withdrawal by Subject
|
251
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
31
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 20.2 • n=3264 Participants
|
|
Sex: Female, Male
Female
|
1972 Participants
n=3264 Participants
|
|
Sex: Female, Male
Male
|
1292 Participants
n=3264 Participants
|
PRIMARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
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|---|---|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2014
|
1.778 infections per 1000 person-year
Interval 0.045 to 9.904
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2015
|
5.083 infections per 1000 person-year
Interval 1.865 to 11.063
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2016
|
7.428 infections per 1000 person-year
Interval 4.061 to 12.463
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2017
|
5.785 infections per 1000 person-year
Interval 3.163 to 9.707
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2018
|
7.079 infections per 1000 person-year
Interval 3.962 to 11.676
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year
Overall calendar years
|
6.123 infections per 1000 person-year
Interval 4.544 to 8.072
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
Incidence rate (IR) of virologically-confirmed symptomatic dengue infection with 95% Confidence Interval (CI) for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all virologically-confirmed dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. A virologically confirmed symptomatic dengue infection is defined as a dengue case confirmed by RT-qPCR. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported.
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 6.558
|
|
Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2015
|
2.541 infections per 1000 person-year
Interval 0.524 to 7.427
|
|
Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2016
|
0.531 infections per 1000 person-year
Interval 0.013 to 2.956
|
|
Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2017
|
0.413 infections per 1000 person-year
Interval 0.01 to 2.302
|
|
Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
Year 2018
|
1.888 infections per 1000 person-year
Interval 0.514 to 4.833
|
|
Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year
Overall calendar years
|
1.102 infections per 1000 person-year
Interval 0.504 to 2.092
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by study site, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Rio at year 2014
|
18.284 infections per 1000 person-year
Interval 9.632 to 34.708
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Rio at year 2015
|
25.666 infections per 1000 person-year
Interval 17.644 to 37.337
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Rio at year 2016
|
27.263 infections per 1000 person-year
Interval 19.592 to 37.938
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Rio at year 2017
|
17.704 infections per 1000 person-year
Interval 12.34 to 25.4
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Rio at year 2018
|
12.761 infections per 1000 person-year
Interval 8.493 to 19.175
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Rio overall calendar years
|
19.597 infections per 1000 person-year
Interval 14.781 to 25.982
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Manaus at year 2014
|
27.098 infections per 1000 person-year
Interval 13.954 to 52.622
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Manaus at year 2015
|
38.039 infections per 1000 person-year
Interval 27.33 to 52.944
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Manaus at year 2016
|
40.405 infections per 1000 person-year
Interval 30.203 to 54.054
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Manaus at year 2017
|
26.239 infections per 1000 person-year
Interval 19.013 to 36.21
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Manaus at year 2018
|
18.913 infections per 1000 person-year
Interval 13.135 to 27.232
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Manaus overall calendar years
|
29.044 infections per 1000 person-year
Interval 22.622 to 37.289
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Salvador at year 2015
|
77.398 infections per 1000 person-year
Interval 52.617 to 113.85
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Salvador at year 2016
|
82.213 infections per 1000 person-year
Interval 65.162 to 103.725
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Salvador at year 2017
|
53.388 infections per 1000 person-year
Interval 40.722 to 69.995
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Salvador at year 2018
|
38.482 infections per 1000 person-year
Interval 27.823 to 53.224
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Salvador overall calendar years
|
59.097 infections per 1000 person-year
Interval 46.242 to 75.525
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Natal at year 2016
|
71.873 infections per 1000 person-year
Interval 51.198 to 100.896
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Natal at year 2017
|
46.674 infections per 1000 person-year
Interval 34.829 to 62.546
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Natal at year 2018
|
33.642 infections per 1000 person-year
Interval 24.002 to 47.154
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Natal overall calendar years
|
51.664 infections per 1000 person-year
Interval 37.852 to 70.516
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Campinas at year 2017
|
1.688 infections per 1000 person-year
Interval 0.234 to 12.152
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Campinas at year 2018
|
1.217 infections per 1000 person-year
Interval 0.171 to 8.67
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
Campinas overall calendar years
|
1.869 infections per 1000 person-year
Interval 0.26 to 13.429
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
All study sites at year 2014
|
18.715 infections per 1000 person-year
Interval 8.748 to 40.034
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
All study sites at year 2015
|
26.271 infections per 1000 person-year
Interval 15.779 to 43.738
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
All study sites at year 2016
|
27.905 infections per 1000 person-year
Interval 17.883 to 43.543
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
All study sites at year 2017
|
18.121 infections per 1000 person-year
Interval 11.609 to 28.286
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
All study sites at year 2018
|
13.061 infections per 1000 person-year
Interval 8.214 to 20.771
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year
All study sites overall calendar years
|
20.059 infections per 1000 person-year
Interval 13.152 to 30.591
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by age category, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≤17 years at year 2014
|
11.826 infections per 1000 person-year
Interval 0.299 to 65.89
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≤17 years at year 2015
|
25.038 infections per 1000 person-year
Interval 8.13 to 58.429
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≤17 years at year 2016
|
47.415 infections per 1000 person-year
Interval 30.057 to 71.146
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≤17 years at year 2017
|
28.345 infections per 1000 person-year
Interval 17.065 to 44.264
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≤17 years at year 2018
|
32.151 infections per 1000 person-year
Interval 19.902 to 49.147
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≤17 years overall calendar years
|
32.970 infections per 1000 person-year
Interval 25.653 to 41.725
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
18-49 years at year 2014
|
9.658 infections per 1000 person-year
Interval 1.992 to 28.224
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
18-49 years at year 2015
|
41.479 infections per 1000 person-year
Interval 27.095 to 60.776
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
18-49 years at year 2016
|
61.410 infections per 1000 person-year
Interval 46.748 to 79.215
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
18-49 years at year 2017
|
46.497 infections per 1000 person-year
Interval 35.123 to 60.38
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
18-49 years at year 2018
|
28.574 infections per 1000 person-year
Interval 19.136 to 41.037
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
18-49 years overall calendar years
|
42.016 infections per 1000 person-year
Interval 35.988 to 48.764
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≥ 50 years at year 2014
|
35.853 infections per 1000 person-year
Interval 13.157 to 78.037
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≥ 50 years at year 2015
|
33.908 infections per 1000 person-year
Interval 17.521 to 59.23
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≥ 50 years at year 2016
|
50.123 infections per 1000 person-year
Interval 31.412 to 75.887
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≥ 50 years at year 2017
|
22.011 infections per 1000 person-year
Interval 11.373 to 38.448
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≥ 50 years at year 2018
|
11.091 infections per 1000 person-year
Interval 3.601 to 25.882
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year
≥ 50 years overall calendar years
|
29.138 infections per 1000 person-year
Interval 22.069 to 37.752
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by gender, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Female at year 2014
|
14.266 infections per 1000 person-year
Interval 4.632 to 33.291
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Female at year 2015
|
37.839 infections per 1000 person-year
Interval 25.144 to 54.688
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Female at year 2016
|
61.579 infections per 1000 person-year
Interval 48.094 to 77.674
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Female at year 2017
|
40.564 infections per 1000 person-year
Interval 30.954 to 52.214
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Female at year 2018
|
29.601 infections per 1000 person-year
Interval 20.948 to 40.63
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Female overall calendar years
|
40.349 infections per 1000 person-year
Interval 34.976 to 46.313
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Male at year 2014
|
23.579 infections per 1000 person-year
Interval 7.656 to 55.026
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Male at year 2015
|
34.056 infections per 1000 person-year
Interval 19.061 to 56.17
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Male at year 2016
|
45.097 infections per 1000 person-year
Interval 31.043 to 63.333
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Male at year 2017
|
28.701 infections per 1000 person-year
Interval 18.914 to 41.758
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Male at year 2018
|
20.355 infections per 1000 person-year
Interval 11.857 to 32.59
|
|
Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year
Male overall calendar years
|
30.694 infections per 1000 person-year
Interval 24.891 to 37.445
|
SECONDARY outcome
Timeframe: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)Population: Analysis was performed on the laboratory confirmed or probable symptomatic dengue cases, excluding those reported without fever or reported before the first visit in the first year.
A primary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and without evidence of previous dengue infection (absence of Ig G antibodies at the previous scheduled visit and absence of laboratory confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported.
Outcome measures
| Measure |
Total Group
n=299 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Primary symptomatic cases in Rio
|
2 Participants
|
|
Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Primary symptomatic cases in Manaus
|
5 Participants
|
|
Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Primary symptomatic cases in Salvador
|
1 Participants
|
|
Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Primary symptomatic cases in Natal
|
4 Participants
|
|
Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Primary symptomatic cases in Campinas
|
0 Participants
|
|
Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Overall primary symptomatic cases
|
12 Participants
|
SECONDARY outcome
Timeframe: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)Population: Analysis was performed on the laboratory confirmed or probable symptomatic dengue cases, excluding those reported without fever or reported before the first visit in the first year.
A secondary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and with evidence of previous dengue infection (presence of IgG antibodies at the previous scheduled visit(s) or laboratory-confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported.
Outcome measures
| Measure |
Total Group
n=299 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Secondary symptomatic cases in Rio
|
51 Participants
|
|
Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Secondary symptomatic cases in Manaus
|
72 Participants
|
|
Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Secondary symptomatic cases in Salvador
|
108 Participants
|
|
Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Secondary symptomatic cases in Natal
|
55 Participants
|
|
Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Secondary symptomatic cases in Campinas
|
1 Participants
|
|
Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases
Overall secondary symptomatic cases
|
287 Participants
|
SECONDARY outcome
Timeframe: At the first visit of the first yearPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline).
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
Seroprevalence at visit 1 in Rio
|
604 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
Seroprevalence at visit 1 in Manaus
|
583 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
Seroprevalence at visit 1 in Salvador
|
580 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
Seroprevalence at visit 1 in Natal
|
534 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
Seroprevalence at visit 1 in Campinas
|
186 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall
Overall seroprevalence at visit 1
|
2487 Participants
|
SECONDARY outcome
Timeframe: At the first visit of the first yearPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline).
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Rio-females
|
372 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Manaus-females
|
381 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Salvador-females
|
341 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Natal-females
|
350 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Campinas-females
|
112 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Overall seroprevalence at visit 1-females
|
1556 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Rio-males
|
232 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Manaus-males
|
202 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Salvador-males
|
239 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Natal-males
|
184 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Seroprevalence at visit 1 in Campinas-males
|
74 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender
Overall seroprevalence at visit 1-males
|
931 Participants
|
SECONDARY outcome
Timeframe: At the first visit of the first yearPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline).
Outcome measures
| Measure |
Total Group
n=3264 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≥50 years in Campinas
|
43 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≤17 years in Rio
|
95 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≤17 years in Manaus
|
85 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≤17 years in Salvador
|
171 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≤17 years in Natal
|
117 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≤17 years in Campinas
|
22 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
Overall first seroprevalence at ≤17 years
|
490 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at 18-49 years in Rio
|
344 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at 18-49 years in Manaus
|
304 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at 18-49 years in Salvador
|
320 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at 18-49 years in Natal
|
297 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at 18-49 years in Campinas
|
121 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
Overall first seroprevalence at 18-49 years
|
1386 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≥50 years in Rio
|
165 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≥50 years in Manaus
|
194 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≥50 years in Salvador
|
89 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
First seroprevalence at ≥50 years in Natal
|
120 Participants
|
|
Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment
Overall first seroprevalence at ≥50 years
|
611 Participants
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year.
Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by site and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=777 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Rio at year 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 99.997
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Rio at year 2015
|
16.570 infections per 1000 person-year
Interval 0.42 to 92.322
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Rio at year 2016
|
48.757 infections per 1000 person-year
Interval 15.831 to 113.782
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Rio at year 2017
|
57.491 infections per 1000 person-year
Interval 18.667 to 134.165
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Rio at year 2018
|
38.610 infections per 1000 person-year
Interval 4.676 to 139.473
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in Rio
|
38.398 infections per 1000 person-year
Interval 20.445 to 65.662
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Manuas at year 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 196.845
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Manuas at year 2015
|
132.246 infections per 1000 person-year
Interval 48.532 to 287.844
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Manuas at year 2016
|
108.548 infections per 1000 person-year
Interval 29.576 to 277.926
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Manuas at year 2017
|
19.956 infections per 1000 person-year
Interval 0.505 to 111.188
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Manuas at year 2018
|
109.613 infections per 1000 person-year
Interval 52.564 to 201.582
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in Manuas
|
86.673 infections per 1000 person-year
Interval 53.652 to 132.489
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Salvador at year 2015
|
0.000 infections per 1000 person-year
Interval 0.0 to 1603.861
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Salvador at year 2016
|
251.256 infections per 1000 person-year
Interval 81.582 to 586.348
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Salvador at year 2017
|
0.000 infections per 1000 person-year
Interval 0.0 to 216.23
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Salvador at year 2018
|
0.000 infections per 1000 person-year
Interval 0.0 to 291.842
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in Salvador
|
96.339 infections per 1000 person-year
Interval 31.281 to 224.823
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Natal at year 2016
|
0.000 infections per 1000 person-year
Interval 0.0 to 174.415
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Natal at year 2017
|
32.648 infections per 1000 person-year
Interval 3.954 to 117.935
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Natal at year 2018
|
150.667 infections per 1000 person-year
Interval 60.576 to 310.432
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in Natal
|
69.838 infections per 1000 person-year
Interval 31.934 to 132.574
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Campinas at year 2017
|
0.000 infections per 1000 person-year
Interval 0.0 to 21.6
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue in Campinas at year 2018
|
12.661 infections per 1000 person-year
Interval 3.45 to 32.416
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in Campinas
|
8.218 infections per 1000 person-year
Interval 2.239 to 21.042
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 66.323
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in 2015
|
64.803 infections per 1000 person-year
Interval 26.054 to 133.519
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in 2016
|
77.584 infections per 1000 person-year
Interval 42.416 to 130.172
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in 2017
|
20.716 infections per 1000 person-year
Interval 8.944 to 40.818
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue in 2018
|
44.396 infections per 1000 person-year
Interval 28.143 to 66.615
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue overall years
|
41.655 infections per 1000 person-year
Interval 31.11 to 54.625
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year.
Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by age category and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=777 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≤17 years in 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 99.565
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≤17 years in 2015
|
37.712 infections per 1000 person-year
Interval 7.777 to 110.211
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≤17 years in 2016
|
51.004 infections per 1000 person-year
Interval 22.02 to 100.498
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≤17 years in 2017
|
19.266 infections per 1000 person-year
Interval 6.255 to 44.959
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≤17 years in 2018
|
64.460 infections per 1000 person-year
Interval 39.374 to 99.553
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue at ≤17 years
|
42.692 infections per 1000 person-year
Interval 29.901 to 59.104
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at 18-49 years in 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 226.034
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at 18-49 years in 2015
|
160.064 infections per 1000 person-year
Interval 43.612 to 409.827
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at 18-49 years in 2016
|
291.262 infections per 1000 person-year
Interval 106.888 to 633.955
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at 18-49 years in 2017
|
22.873 infections per 1000 person-year
Interval 2.77 to 82.625
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at 18-49 years in 2018
|
14.092 infections per 1000 person-year
Interval 1.707 to 50.907
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue at 18-49 years
|
48.065 infections per 1000 person-year
Interval 26.278 to 80.646
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≥ 50 years in 2014
|
0.000 infections per 1000 person-year
Interval 0.0 to 1639.502
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≥ 50 years in 2015
|
0.000 infections per 1000 person-year
Interval 0.0 to 1063.078
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≥ 50 years in 2016
|
0.000 infections per 1000 person-year
Interval 0.0 to 1225.541
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≥ 50 years in 2017
|
25.504 infections per 1000 person-year
Interval 0.646 to 142.098
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at ≥ 50 years in 2018
|
15.179 infections per 1000 person-year
Interval 0.384 to 84.573
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue at ≥ 50 years
|
17.570 infections per 1000 person-year
Interval 2.128 to 63.469
|
SECONDARY outcome
Timeframe: At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar yearsPopulation: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year.
Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by gender and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.
Outcome measures
| Measure |
Total Group
n=777 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2014- females
|
0.000 infections per 1000 person-year
Interval 0.0 to 129.027
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2015- females
|
36.792 infections per 1000 person-year
Interval 4.456 to 132.904
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2016- females
|
91.002 infections per 1000 person-year
Interval 39.288 to 179.311
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2017- females
|
25.219 infections per 1000 person-year
Interval 8.189 to 58.854
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2018- females
|
43.176 infections per 1000 person-year
Interval 22.31 to 75.42
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall Primary inapparent dengue- females
|
41.728 infections per 1000 person-year
Interval 27.499 to 60.712
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2014- males
|
0.000 infections per 1000 person-year
Interval 0.0 to 136.423
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2015- males
|
93.179 infections per 1000 person-year
Interval 30.255 to 217.449
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2016- males
|
64.837 infections per 1000 person-year
Interval 23.794 to 141.122
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2017- males
|
15.965 infections per 1000 person-year
Interval 3.292 to 46.657
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Primary inapparent dengue at year 2018- males
|
45.807 infections per 1000 person-year
Interval 22.866 to 81.961
|
|
Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit
Overall primary inapparent dengue- males
|
41.577 infections per 1000 person-year
Interval 26.907 to 61.376
|
SECONDARY outcome
Timeframe: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who were defined as suspected dengue cases, excluding those without fever or reported before the first visit.
To describe symptoms and spectrum of dengue disease in the study population for the suspected dengue cases, excluding those reported without fever. Suspected symptomatic dengue case= Febrile illness with body temperature ≥ 38°C measured (by any route) on at least two consecutive days and less than 14 days with or without the presence of other dengue symptoms or signs, without an obvious aetiology unrelated to dengue, based on investigator's judgement; Lab-confirmed = laboratory-confirmed symptomatic dengue cases; Probable = probable symptomatic dengue cases; Negative = negative symptomatic dengue cases; Indeterminate = indeterminate symptomatic dengue case( not classified as laboratory confirmed case, probable case or negative case); Severe dengue episode = at least one criteria met for severe dengue (in accordance to the "dengue with warning signs" and "severe dengue" definitions in the 2009 WHO guidelines for dengue).
Outcome measures
| Measure |
Total Group
n=1284 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe dengue episode- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe dengue episode- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe dengue episode- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe dengue episode- probable
|
1 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe dengue episode- total
|
1 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe plasma leakage- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe plasma leakage- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe plasma leakage- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe plasma leakage- probable
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe plasma leakage- total
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Fluid accumulation- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Fluid accumulation- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Fluid accumulation- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Fluid accumulation- probable
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Fluid accumulation- total
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe bleeding- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe bleeding- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe bleeding- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe bleeding- probable
|
1 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Severe bleeding- total
|
1 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Liver involvement- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Liver involvement- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Liver involvement- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Liver involvement- probable
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Liver involvement- total
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Central Nervous System involvement- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Central Nervous System involvement- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Central Nervous System involvement- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Central Nervous System involvement- probable
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Central Nervous System involvement- total
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Heart and other organs involvement- indeterminate
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Heart and other organs involvement- lab-confirmed
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Heart and other organs involvement- negative
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Heart and other organs involvement- probable
|
0 Participants
|
|
Number of Suspected Dengue Cases With Severity Criteria
Heart and other organs involvement- total
|
0 Participants
|
SECONDARY outcome
Timeframe: From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)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.
Outcome measures
| Measure |
Total Group
n=3300 Participants
Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed.
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure
|
0 Participants
|
Adverse Events
Total Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 31 deaths
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