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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 : February 1, 2018
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 originally enrolled in the study, one subject was excluded due to protocol violation.
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.
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, 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 Number of Laboratory Confirmed Symptomatic Dengue Infection Cases
Hide Description Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection 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.
Time Frame At Year 1 (2012)
Show Outcome Measure DataHide 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, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 665 608
Measure Type: Number
Unit of Measure: Cases
7 7
2.Primary Outcome
Title Number of Laboratory Confirmed Symptomatic Dengue Virus Cases
Hide Description Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection 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.
Time Frame At Year 2 (2013)
Show Outcome Measure DataHide 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, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 794 813
Measure Type: Number
Unit of Measure: Cases
8 21
3.Primary Outcome
Title Number of Laboratory Confirmed Symptomatic Dengue Cases
Hide Description Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection 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.
Time Frame At Year 3 (2014)
Show Outcome Measure DataHide 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, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 517 852
Measure Type: Number
Unit of Measure: Cases
2 12
4.Secondary Outcome
Title Number of Subjects With Immunoglobulin Type G (IgG) Antibodies Against Dengue
Hide Description Immune response against dengue was assessed via Enzyme-linked Immunosorbent Assay (ELISA).
Time Frame From Day 0 to Year 3
Show Outcome Measure DataHide 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 307
Measure Type: Count of Participants
Unit of Measure: Participants
IgG, 5 years old at enrollment Number Analyzed 307 participants
100
  32.6%
IgG, 6 years old at enrollment Number Analyzed 240 participants
105
  43.8%
IgG, 7 years old at enrollment Number Analyzed 271 participants
103
  38.0%
IgG, 8 years old at enrollment Number Analyzed 267 participants
123
  46.1%
IgG, 9 years old at enrollment Number Analyzed 249 participants
123
  49.4%
IgG, 10 years old at enrollment Number Analyzed 247 participants
142
  57.5%
IgG, 11 years old at enrollment Number Analyzed 212 participants
146
  68.9%
IgG, 12 years old at enrollment Number Analyzed 185 participants
127
  68.6%
IgG, 13 years old at enrollment Number Analyzed 126 participants
90
  71.4%
5.Secondary Outcome
Title Number of Subjects With Asymptomatic Dengue Primary 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.
Time Frame From Day 0 to Year 3
Show Outcome Measure DataHide 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 695
Measure Type: Count of Participants
Unit of Measure: Participants
Asymptomatic dengue, 2012 Number Analyzed 695 participants
175
  25.2%
Asymptomatic dengue, 2013 Number Analyzed 673 participants
59
   8.8%
Asymptomatic dengue, 2014 Number Analyzed 574 participants
29
   5.1%
6.Secondary Outcome
Title Number of Subjects With Laboratory Confirmed and Probable 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); 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
Show Outcome Measure DataHide 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 142
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%
7.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
Show Outcome Measure DataHide 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 21
Measure Type: Count of Participants
Unit of Measure: Participants
DENV-4, 2012
8
  38.1%
DENV-4, 2013
6
  28.6%
DENV-1, 2014
7
  33.3%
8.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 or seropositive, respectively. Analysis was done by calendar year and age strata.
Time Frame From Day 0 to Year 3
Show Outcome Measure DataHide 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, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 417 242
Measure Type: Count of Participants
Unit of Measure: Participants
Primary lab-conf. sympt. dengue, 2012 Number Analyzed 417 participants 209 participants
3
   0.7%
4
   1.9%
Primary lab-conf. sympt. dengue, 2013 Number Analyzed 384 participants 242 participants
4
   1.0%
8
   3.3%
Primary lab-conf. sympt. dengue, 2014 Number Analyzed 243 participants 235 participants
2
   0.8%
2
   0.9%
9.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 seronegative or seropositive, respectively.
Time Frame From Day 0 to Year 3
Show Outcome Measure DataHide 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, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
Overall Number of Participants Analyzed 401 610
Measure Type: Count of Participants
Unit of Measure: Participants
Secondary lab-conf.sympt. dengue, 2012 Number Analyzed 244 participants 396 participants
4
   1.6%
3
   0.8%
Secondary lab-conf.sympt. dengue, 2013 Number Analyzed 401 participants 569 participants
4
   1.0%
13
   2.3%
Secondary lab-conf.sympt. dengue, 2014 Number Analyzed 267 participants 610 participants
0
   0.0%
10
   1.6%
10.Secondary Outcome
Title Number of Working Days Missed of Primary Care Giver 1 and 2
Hide Description The number of days off work from caregiver were recorded as part of health economics indirect resource utilization.
Time Frame Up to Day 35 post laboratory confirmed dengue onset
Show Outcome Measure DataHide 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 12
Mean (Standard Deviation)
Unit of Measure: Days
Care giver 1 Number Analyzed 12 participants
2.4  (1.88)
Care giver 2 Number Analyzed 4 participants
1.8  (0.96)
11.Secondary Outcome
Title Caregiver Absenteeism Associated With Subject Dengue Illness
Hide Description The number of suspected dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization.
Time Frame Up to Day 35 post laboratory confirmed dengue onset
Show Outcome Measure DataHide 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 57
Measure Type: Number
Unit of Measure: Suspected dengue infection
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
12.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.
Time Frame Up to Day 35 post laboratory confirmed dengue onset
Show Outcome Measure DataHide 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 49
Mean (Standard Deviation)
Unit of Measure: Days
4.4  (2.58)
13.Secondary Outcome
Title Subjects Absenteeism Associated With Dengue Illness
Hide Description The number of suspected dengue infections with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance.
Time Frame Up to Day 35 post laboratory confirmed dengue onset
Show Outcome Measure DataHide 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 57
Measure Type: Number
Unit of Measure: Suspected dengue infection
Positive 49
Negative 5
Missing confirmed 3
Not applicable 0
14.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame From Day 0 to Year 3
Show Outcome Measure DataHide Outcome Measure Data
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%
15.Secondary Outcome
Title Direct Medical Resource Associated With Suspected Dengue Cases
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
Show Outcome Measure DataHide 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 57
Measure Type: Number
Unit of Measure: Suspected dengue infection
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
16.Secondary Outcome
Title Number of Hospitalization Days Due to Suspected 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
Show Outcome Measure DataHide 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 1
Mean (Standard Deviation)
Unit of Measure: Days
19.0  (0)
17.Secondary Outcome
Title Dengue Infection Episodes Related Temperature
Hide Description Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.
Time Frame From Day 0 to Year 3
Show Outcome Measure DataHide 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 55
Mean (Standard Deviation)
Unit of Measure: °C
37.18  (0.952)
18.Secondary Outcome
Title Number of Dengue Episodes With Any Temperature Interval
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
Show Outcome Measure DataHide 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 57
Measure Type: Number
Unit of Measure: Dengue episodes
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
19.Secondary Outcome
Title Number of 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
Show Outcome Measure DataHide 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 57
Measure Type: Number
Unit of Measure: Dengue episodes
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 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 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   0/2117 (0.00%) 
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   0/2117 (0.00%) 
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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: February 1, 2018