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Study to Evaluate the Incidence, Clinical Characteristics and Economic Burden of Dengue in Brazilian Children

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ClinicalTrials.gov Identifier: NCT01391819
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : April 26, 2017
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Dengue
Interventions Other: Data collection
Procedure: Blood sample collection
Enrollment 2117
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Dengue Group
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2116
Completed 1714
Not Completed 402
Reason Not Completed
Withdrawal by Subject             56
Migrated/moved from study area             82
Lost to Follow-up             252
Death             3
Other             9
Arm/Group Title Dengue Group
Hide Arm/Group Description 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 Number of Baseline Participants 2116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2116 participants
8.997  (2.4637)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2116 participants
Female
1096
  51.8%
Male
1020
  48.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
Hide Description 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.
Time Frame At Year 1 (2012)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 729 688
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases in 1000 person-years
10.5
(3.6 to 30.5)
11.5
(0.1 to 1552.7)
2.Primary Outcome
Title Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
Hide Description 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.
Time Frame At Year 2 (2013)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 818 932
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases in 1000 person-years
10.1
(2.3 to 44.9)
25.8
(13.3 to 38.3)
3.Primary Outcome
Title Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
Hide Description 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.
Time Frame At Year 3 (2014)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 576 1138
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases in 1000 person-years
3.9
(1.0 to 15.2)
14.1
(-0.6 to 28.8)
4.Secondary Outcome
Title Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
Hide Description 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).
Time Frame At Day 0 (At enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 2104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of subjects
IgG, 5 years old at enrollment Number Analyzed 307 participants
32.57
(26.10 to 39.79)
IgG, 6 years old at enrollment Number Analyzed 240 participants
45.18
(42.86 to 47.51)
IgG, 7 years old at enrollment Number Analyzed 271 participants
38.86
(31.03 to 47.31)
IgG, 8 years old at enrollment Number Analyzed 267 participants
49.60
(37.39 to 61.85)
IgG, 9 years old at enrollment Number Analyzed 249 participants
50.20
(39.96 to 60.43)
IgG, 10 years old at enrollment Number Analyzed 247 participants
57.27
(49.42 to 64.78)
IgG, 11 years old at enrollment Number Analyzed 212 participants
68.87
(62.64 to 74.48)
IgG, 12 years old at enrollment Number Analyzed 185 participants
69.16
(61.56 to 75.84)
IgG, 13 years old at enrollment Number Analyzed 126 participants
70.16
(55.75 to 81.45)
IgG, Total Number Analyzed 2104 participants
54.08
(46.59 to 61.40)
5.Secondary Outcome
Title Proportion of Subjects With Primary Asymptomatic Dengue Infection
Hide Description 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.
Time Frame From Day 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 1942
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
Asymptomatic dengue, 2012 Number Analyzed 695 participants
20.27
(13.63 to 29.07)
Asymptomatic dengue, 2013 Number Analyzed 673 participants
8.70
(6.88 to 10.94)
Asymptomatic dengue, 2014 Number Analyzed 574 participants
5.14
(4.40 to 6.01)
Total Number Analyzed 1942 participants
13.09
(11.02 to 15.49)
6.Secondary Outcome
Title Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
Hide Description 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.
Time Frame From Year 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 188
Measure Type: Count of Participants
Unit of Measure: Participants
Primary, laboratory confirmed cases Number Analyzed 42 participants
23
  54.8%
Primary, probable cases Number Analyzed 42 participants
19
  45.2%
Secondary, laboratory confirmed cases Number Analyzed 142 participants
33
  23.2%
Secondary, probable cases Number Analyzed 142 participants
109
  76.8%
Unknown, laboratory confirmed cases Number Analyzed 4 participants
1
  25.0%
Unknown, probable cases Number Analyzed 4 participants
3
  75.0%
Total, laboratory confirmed cases Number Analyzed 188 participants
57
  30.3%
Total, probable cases Number Analyzed 188 participants
131
  69.7%
7.Secondary Outcome
Title Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
Hide Description 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.
Time Frame At Year 1 (2012)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 818 1138
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases in 1000 person-years
30.3
(13.0 to 47.5)
31.4
(14.8 to 48.1)
8.Secondary Outcome
Title Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
Hide Description 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.
Time Frame At Year 2 (2013)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 818 1138
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases in 1000 person-years
56.7
(22.1 to 91.2)
66.6
(40.0 to 93.2)
9.Secondary Outcome
Title Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
Hide Description 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.
Time Frame At Year 3 (2014)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 818 1138
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Cases in 1000 person-years
13.6
(1.6 to 118.0)
33.1
(10.0 to 56.2)
10.Secondary Outcome
Title Number of Dengue Infection Cases by Virus Type (DENV)
Hide Description Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR.
Time Frame From Day 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: Dengue infection cases
DENV-4, 2012 8
DENV-4, 2013 6
DENV-1, 2014 7
11.Secondary Outcome
Title Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description 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.
Time Frame At Year 1 (2012)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 458 238
Measure Type: Number
Unit of Measure: Dengue infection cases
3 4
12.Secondary Outcome
Title Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description 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.
Time Frame At Year 2 (2013)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 404 285
Measure Type: Number
Unit of Measure: Dengue infection cases
4 8
13.Secondary Outcome
Title Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description 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.
Time Frame At Year 3 (2014)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 273 318
Measure Type: Number
Unit of Measure: Dengue infection cases
2 2
14.Secondary Outcome
Title Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description 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.
Time Frame At Year 1 (2012)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 268 450
Measure Type: Number
Unit of Measure: Dengue infection cases
4 3
15.Secondary Outcome
Title Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description 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.
Time Frame At Year 2 (2013)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 422 671
Measure Type: Number
Unit of Measure: Dengue infection cases
4 13
16.Secondary Outcome
Title Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description 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.
Time Frame At Year 3 (2014)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue 5-9Y Group Dengue 10-17Y Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 300 824
Measure Type: Number
Unit of Measure: Dengue infection cases
0 10
17.Secondary Outcome
Title Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
Hide Description The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.
Time Frame From 21 up to 35 days post laboratory confirmed dengue onset
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Days
2.4  (1.88)
18.Secondary Outcome
Title Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
Hide Description The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.
Time Frame From 21 up to 35 days post laboratory confirmed dengue onset
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: Days
1.8  (0.96)
19.Secondary Outcome
Title Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
Hide Description 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.
Time Frame From 21 up to 35 days post laboratory confirmed dengue onset
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: Dengue infection cases
Primary care giver 1, Positive 12
Primary care giver 1, Negative 42
Primary care giver 1, Missing confirmed 3
Primary care giver 1, Not applicable 0
Primary care giver 2, Positive 4
Primary care giver 2, Negative 46
Primary care giver 2, Missing confirmed 3
Primary care giver 2, Not applicable 4
20.Secondary Outcome
Title Number of School Days Missed by Subjects
Hide Description 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.
Time Frame From 21 up to 35 days post laboratory confirmed dengue onset
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: Days
4.4  (2.58)
21.Secondary Outcome
Title Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
Hide Description 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.
Time Frame From 21 up to 35 days post laboratory confirmed dengue onset
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: Dengue infection cases
Positive 49
Negative 5
Missing confirmed 3
Not applicable 0
22.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame From Day 0 to Year 3
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Hide Analysis Population Description
The analysis was performed on the Total cohort, which included all subjects enrolled in the study.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 2117
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
23.Secondary Outcome
Title Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Hide Description Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures
Time Frame From Day 0 to Year 3
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Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: Dengue infection cases
Subject hospitalized, positive 2
Subject hospitalized, negative 54
Subject hospitalized, unknown 1
Hospitalized in a study hospital, positive 1
Hospitalized in a study hospital, negative 1
Hospitalized in a study hospital, unknown 55
24.Secondary Outcome
Title Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases
Hide Description Length of hospitalization was part of the direct medical resource, associated with dengue infection.
Time Frame From Day 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Days
19.0  (0)
25.Secondary Outcome
Title Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature
Hide Description Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.
Time Frame From Day 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: °C
37.18  (0.952)
26.Secondary Outcome
Title Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
Hide Description 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.
Time Frame From Day 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: dengue infection cases
33.5 - 33.9 °C 0
34 - 34.4 °C 0
34.5 - 34.9 °C 0
35 - 35.4 °C 2
35.5 - 35.9 °C 2
36 - 36.4 °C 8
36.5 - 36.9 °C 11
37 - 37.4 °C 14
37.5 - 37.9 °C 7
38 - 38.4 °C 5
38.5 - 38.9 °C 4
39 - 39.4 °C 1
39.5 - 39.9 °C 1
Unknown 2
27.Secondary Outcome
Title Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
Hide Description Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.
Time Frame From Day 0 to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Dengue Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: dengue infection cases
Headache 43
Retroorbital pain [eye pain] 22
Myalgia 29
Joint pain 10
Chills 7
Rash 3
Itching 8
At least one digestive sign among first symptoms 38
Abdominal pain 17
Nausea or vomiting 29
Diarrhea 10
At least one respiratory sign among first symptoms 32
Cough 20
Nasal congestion 10
Sore throat 23
Dyspnea 0
At least one hemorrhagic sign among first symptoms 4
Petechia 3
Purpura/ecchymosis 0
Hematemesis [vomiting of blood] 1
Melena/hematochezia [blood in stool] 0
Gingival bleeding 0
Epistaxis 0
Urinary tract bleeding 0
Unusual vaginal bleeding 0
At least one other signs among first symptoms 33
Pallor or cool skin 2
Conjunctivis 2
Lethargy or restlessness 3
Dizziness 11
Thoracic pain 0
Other 28
Time Frame Serious Adverse Events were collected on the enrolled subjects throughout the study period (from Day 0 to Year 3).
Adverse Event Reporting Description Adverse Events were not collected as blood sampling was the only invasive procedure performed.
 
Arm/Group Title Dengue Group
Hide Arm/Group Description 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.
All-Cause Mortality
Dengue Group
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Dengue Group
Affected / at Risk (%)
Total   0/2117 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dengue Group
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01391819     History of Changes
Other Study ID Numbers: 112994
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: March 16, 2017
Results First Posted: April 26, 2017
Last Update Posted: June 25, 2019