Trial Outcomes & Findings for Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children (NCT NCT01391819)
NCT ID: NCT01391819
Last Updated: 2019-06-25
Results Overview
Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
COMPLETED
NA
2117 participants
At Year 1 (2012)
2019-06-25
Participant Flow
Out of 2117 subjects enrolled in the study, one subject was excluded due to protocol violation. Subjects attended 3 to 4 visits, during a 2 to 3 Year period: subjects enrolled in 2011-2012 who consented for participation of one additional year had 4 scheduled visits over 3 years, and those enrolled in 2013 had 3 scheduled visits over 2 years.
Participant milestones
| Measure |
Dengue Group
Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
|
|---|---|
|
Overall Study
STARTED
|
2116
|
|
Overall Study
COMPLETED
|
1714
|
|
Overall Study
NOT COMPLETED
|
402
|
Reasons for withdrawal
| Measure |
Dengue Group
Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
56
|
|
Overall Study
Migrated/moved from study area
|
82
|
|
Overall Study
Lost to Follow-up
|
252
|
|
Overall Study
Death
|
3
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dengue Group
n=2116 Participants
Subjects, male and female, aged 5-13 years at the time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
|
|---|---|
|
Age, Continuous
|
8.997 Years
STANDARD_DEVIATION 2.4637 • n=2116 Participants
|
|
Sex: Female, Male
Female
|
1096 Participants
n=2116 Participants
|
|
Sex: Female, Male
Male
|
1020 Participants
n=2116 Participants
|
PRIMARY outcome
Timeframe: At Year 1 (2012)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=729 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=688 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
|
10.5 Cases in 1000 person-years
Interval 3.6 to 30.5
|
11.5 Cases in 1000 person-years
Interval 0.1 to 1552.7
|
PRIMARY outcome
Timeframe: At Year 2 (2013)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=818 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=932 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
|
10.1 Cases in 1000 person-years
Interval 2.3 to 44.9
|
25.8 Cases in 1000 person-years
Interval 13.3 to 38.3
|
PRIMARY outcome
Timeframe: At Year 3 (2014)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=576 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=1138 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
|
3.9 Cases in 1000 person-years
Interval 1.0 to 15.2
|
14.1 Cases in 1000 person-years
Interval -0.6 to 28.8
|
SECONDARY outcome
Timeframe: At Day 0 (At enrollment)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
This outcome measures the occurrence of past dengue infections among subjects who had laboratory results. Proportion was estimated from logistic generalized estimating equations models (GEE) taking the clustering effect of the school into account and was presented per subject enrolment age. Immune response against dengue was assessed via Enzyme-linked Immunosorbent Assay (ELISA).
Outcome measures
| Measure |
Dengue 5-9Y Group
n=2104 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 5 years old at enrollment
|
32.57 Proportion of subjects
Interval 26.1 to 39.79
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 6 years old at enrollment
|
45.18 Proportion of subjects
Interval 42.86 to 47.51
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 7 years old at enrollment
|
38.86 Proportion of subjects
Interval 31.03 to 47.31
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 8 years old at enrollment
|
49.60 Proportion of subjects
Interval 37.39 to 61.85
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 9 years old at enrollment
|
50.20 Proportion of subjects
Interval 39.96 to 60.43
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 10 years old at enrollment
|
57.27 Proportion of subjects
Interval 49.42 to 64.78
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 11 years old at enrollment
|
68.87 Proportion of subjects
Interval 62.64 to 74.48
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 12 years old at enrollment
|
69.16 Proportion of subjects
Interval 61.56 to 75.84
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, 13 years old at enrollment
|
70.16 Proportion of subjects
Interval 55.75 to 81.45
|
—
|
|
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
IgG, Total
|
54.08 Proportion of subjects
Interval 46.59 to 61.4
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Asymptomatic dengue primary infection was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits, without suspicion of dengue. Proportion of asymptomatic dengue primary infection was analyzed among subjects who had no past dengue infection reported before the beginning of the period.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=1942 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Proportion of Subjects With Primary Asymptomatic Dengue Infection
Asymptomatic dengue, 2012
|
20.27 proportion of subjects
Interval 13.63 to 29.07
|
—
|
|
Proportion of Subjects With Primary Asymptomatic Dengue Infection
Asymptomatic dengue, 2013
|
8.70 proportion of subjects
Interval 6.88 to 10.94
|
—
|
|
Proportion of Subjects With Primary Asymptomatic Dengue Infection
Asymptomatic dengue, 2014
|
5.14 proportion of subjects
Interval 4.4 to 6.01
|
—
|
|
Proportion of Subjects With Primary Asymptomatic Dengue Infection
Total
|
13.09 proportion of subjects
Interval 11.02 to 15.49
|
—
|
SECONDARY outcome
Timeframe: From Year 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
A case of primary or secondary symptomatic dengue infection was defined as laboratory confirmed or probable symptomatic dengue case whose previous sample collected at scheduled Visits 1- 4 (Day 0- Year 3) to detect anti-dengue IgG antibodies was seronegative or seropositive, respectively. A probable dengue case was defined as a suspected symptomatic dengue case with the following laboratory findings: -anti-dengue IgM or anti-dengue IgG positivity in at least one sample (in either blood sample 1 or 2) AND no evidence of viremia (negative dengue virus identification through RT-qPCR) in blood sample 1 AND no evidence of anti-dengue Ig M or IgG seroconversion between blood sample 1 and blood sample 2.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=188 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Secondary, laboratory confirmed cases
|
33 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Secondary, probable cases
|
109 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Unknown, laboratory confirmed cases
|
1 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Unknown, probable cases
|
3 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Total, laboratory confirmed cases
|
57 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Total, probable cases
|
131 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Primary, laboratory confirmed cases
|
23 Participants
|
—
|
|
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Primary, probable cases
|
19 Participants
|
—
|
SECONDARY outcome
Timeframe: At Year 1 (2012)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=818 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=1138 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
|
30.3 Cases in 1000 person-years
Interval 13.0 to 47.5
|
31.4 Cases in 1000 person-years
Interval 14.8 to 48.1
|
SECONDARY outcome
Timeframe: At Year 2 (2013)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=818 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=1138 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
|
56.7 Cases in 1000 person-years
Interval 22.1 to 91.2
|
66.6 Cases in 1000 person-years
Interval 40.0 to 93.2
|
SECONDARY outcome
Timeframe: At Year 3 (2014)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category "number of subjects analysed" has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=818 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=1138 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
|
13.6 Cases in 1000 person-years
Interval 1.6 to 118.0
|
33.1 Cases in 1000 person-years
Interval 10.0 to 56.2
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=21 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Dengue Infection Cases by Virus Type (DENV)
DENV-4, 2012
|
8 Dengue infection cases
|
—
|
|
Number of Dengue Infection Cases by Virus Type (DENV)
DENV-4, 2013
|
6 Dengue infection cases
|
—
|
|
Number of Dengue Infection Cases by Virus Type (DENV)
DENV-1, 2014
|
7 Dengue infection cases
|
—
|
SECONDARY outcome
Timeframe: At Year 1 (2012)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=458 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=238 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
|
3 Dengue infection cases
|
4 Dengue infection cases
|
SECONDARY outcome
Timeframe: At Year 2 (2013)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=404 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=285 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
|
4 Dengue infection cases
|
8 Dengue infection cases
|
SECONDARY outcome
Timeframe: At Year 3 (2014)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=273 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=318 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
|
2 Dengue infection cases
|
2 Dengue infection cases
|
SECONDARY outcome
Timeframe: At Year 1 (2012)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=268 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=450 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
|
4 Dengue infection cases
|
3 Dengue infection cases
|
SECONDARY outcome
Timeframe: At Year 2 (2013)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=422 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=671 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
|
4 Dengue infection cases
|
13 Dengue infection cases
|
SECONDARY outcome
Timeframe: At Year 3 (2014)Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category "number of subjects analysed" has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=300 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
n=824 Participants
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
|
0 Dengue infection cases
|
10 Dengue infection cases
|
SECONDARY outcome
Timeframe: From 21 up to 35 days post laboratory confirmed dengue onsetPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=12 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
|
2.4 Days
Standard Deviation 1.88
|
—
|
SECONDARY outcome
Timeframe: From 21 up to 35 days post laboratory confirmed dengue onsetPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=4 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
|
1.8 Days
Standard Deviation 0.96
|
—
|
SECONDARY outcome
Timeframe: From 21 up to 35 days post laboratory confirmed dengue onsetPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
The number of laboratory confirmed dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=57 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 1, Positive
|
12 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 1, Negative
|
42 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 1, Missing confirmed
|
3 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 1, Not applicable
|
0 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 2, Positive
|
4 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 2, Negative
|
46 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 2, Missing confirmed
|
3 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Primary care giver 2, Not applicable
|
4 Dengue infection cases
|
—
|
SECONDARY outcome
Timeframe: From 21 up to 35 days post laboratory confirmed dengue onsetPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
The number of school days missed by subjects due to dengue infection were recorded as part of the dengue active surveillance and indirect resource utilization associated with symptomatic dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=49 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of School Days Missed by Subjects
|
4.4 Days
Standard Deviation 2.58
|
—
|
SECONDARY outcome
Timeframe: From 21 up to 35 days post laboratory confirmed dengue onsetPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
The number of laboratory confirmed dengue infection cases with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance and indirect resource utilization associated with symptomatic dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=57 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
Positive
|
49 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
Negative
|
5 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
Missing confirmed
|
3 Dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
Not applicable
|
0 Dengue infection cases
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the Total cohort, which included all subjects enrolled in the study.
Serious adverse events (SAEs) were collected on the enrolled subjects. SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=2117 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures
Outcome measures
| Measure |
Dengue 5-9Y Group
n=57 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Subject hospitalized, positive
|
2 Dengue infection cases
|
—
|
|
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Subject hospitalized, negative
|
54 Dengue infection cases
|
—
|
|
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Subject hospitalized, unknown
|
1 Dengue infection cases
|
—
|
|
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Hospitalized in a study hospital, positive
|
1 Dengue infection cases
|
—
|
|
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Hospitalized in a study hospital, negative
|
1 Dengue infection cases
|
—
|
|
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Hospitalized in a study hospital, unknown
|
55 Dengue infection cases
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Length of hospitalization was part of the direct medical resource, associated with dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=1 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases
|
19.0 Days
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=55 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature
|
37.18 °C
Standard Deviation 0.952
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Temperature intervals assessed varied from hypothermia 33.5 to 36.4 degrees Celsius (°C), to normal temperature 36.5-35.9 °C and hyperthermia 37 - 39.9 °C, or were unknown.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=57 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
33.5 - 33.9 °C
|
0 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
34 - 34.4 °C
|
0 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
34.5 - 34.9 °C
|
0 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
35 - 35.4 °C
|
2 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
35.5 - 35.9 °C
|
2 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
36 - 36.4 °C
|
8 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
36.5 - 36.9 °C
|
11 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
37 - 37.4 °C
|
14 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
37.5 - 37.9 °C
|
7 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
38 - 38.4 °C
|
5 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
38.5 - 38.9 °C
|
4 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
39 - 39.4 °C
|
1 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
39.5 - 39.9 °C
|
1 dengue infection cases
|
—
|
|
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
Unknown
|
2 dengue infection cases
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Year 3Population: The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.
Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.
Outcome measures
| Measure |
Dengue 5-9Y Group
n=57 Participants
Subjects belonging to Dengue Group, male and female, aged 5-9 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
Dengue 10-17Y Group
Subjects belonging to Dengue Group, male and female, aged 10-17 years at the time of the visit, enrolled for data collection and blood sampling for dengue evaluation.
|
|---|---|---|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Gingival bleeding
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Headache
|
43 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Retroorbital pain [eye pain]
|
22 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Myalgia
|
29 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Joint pain
|
10 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Chills
|
7 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Rash
|
3 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Itching
|
8 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
At least one digestive sign among first symptoms
|
38 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Abdominal pain
|
17 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Nausea or vomiting
|
29 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Diarrhea
|
10 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
At least one respiratory sign among first symptoms
|
32 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Cough
|
20 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Nasal congestion
|
10 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Sore throat
|
23 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Dyspnea
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
At least one hemorrhagic sign among first symptoms
|
4 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Petechia
|
3 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Purpura/ecchymosis
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Hematemesis [vomiting of blood]
|
1 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Melena/hematochezia [blood in stool]
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Epistaxis
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Urinary tract bleeding
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Unusual vaginal bleeding
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
At least one other signs among first symptoms
|
33 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Pallor or cool skin
|
2 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Conjunctivis
|
2 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Lethargy or restlessness
|
3 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Dizziness
|
11 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Thoracic pain
|
0 dengue infection cases
|
—
|
|
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Other
|
28 dengue infection cases
|
—
|
Adverse Events
Dengue Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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