Dengue
Conditions
Keywords
Brazil, Incidence, Dengue virus, Dengue, Dengue infection
Brief summary
The aim of this study is to establish an active surveillance in order to generate dengue disease burden estimates including incidence rates, prevalence data, clinical presentation and cost of illness in Forteleza (Brazil).
Detailed description
Prospective cohort study. The study period initially planned to be two years, is extended by one year to cover one additional dengue season.
Interventions
OTHERData collection
Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.
PROCEDUREBlood sample collection
A blood sample will be collected at each of the three scheduled study visits and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue diagnosis.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female between 5 and 13 years of age (including children at least 5 years of age and excluding children who reached their fourteenth birthday) at the time of enrollment. * Written informed consent (and assent when applicable). * Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol (e.g. willingness to do a hospital visit in case of dengue suspicion, willingness to attend the study hospital return for follow-up visits, able to observe for signs of dengue, understand how to take a temperature, etc). * Subjects who plan to attend one of the study schools for two school years following enrollment.
Exclusion criteria
* Subjects planning to move from the study area during the two school years following enrollment. * Child in care. * Enrollment in another study that would conflict with the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | At Year 1 (2012) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Primary Asymptomatic Dengue Infection | From Day 0 to Year 3 | 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. |
| Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases | From Year 0 to Year 3 | 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. |
| Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | At Year 1 (2012) | 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. |
| Number of Dengue Infection Cases by Virus Type (DENV) | From Day 0 to Year 3 | Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR. |
| Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | At Year 1 (2012) | 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. |
| Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | At Year 1 (2012) | 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. |
| Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases | From 21 up to 35 days post laboratory confirmed dengue onset | The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection. |
| Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases | From 21 up to 35 days post laboratory confirmed dengue onset | The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection. |
| Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | At Day 0 (At enrollment) | 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). |
| Number of School Days Missed by Subjects | From 21 up to 35 days post laboratory confirmed dengue onset | 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. |
| Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | From 21 up to 35 days post laboratory confirmed dengue onset | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Year 3 | 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. |
| Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | From Day 0 to Year 3 | Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures |
| Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases | From Day 0 to Year 3 | Length of hospitalization was part of the direct medical resource, associated with dengue infection. |
| Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature | From Day 0 to Year 3 | Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection. |
| Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases | From Day 0 to Year 3 | 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. |
| Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | From Day 0 to Year 3 | Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms. |
| Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | From 21 up to 35 days post laboratory confirmed dengue onset | 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. |
Countries
Brazil
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2,116 |
| Total | 2,116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 3 |
| Overall Study | Lost to Follow-up | 252 |
| Overall Study | Migrated/moved from study area | 82 |
| Overall Study | Other | 9 |
| Overall Study | Withdrawal by Subject | 56 |
Baseline characteristics
| Characteristic | Dengue Group | — |
|---|---|---|
| Age, Continuous | 8.997 Years STANDARD_DEVIATION 2.4637 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1096 Participants | — |
| Sex: Female, Male Male | 1020 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 2,117 |
Outcome results
Primary
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 10.5 Cases in 1000 person-years |
| Dengue 10-17Y Group | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 11.5 Cases in 1000 person-years |
Primary
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 10.1 Cases in 1000 person-years |
| Dengue 10-17Y Group | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 25.8 Cases in 1000 person-years |
Primary
Incidence of All Laboratory-confirmed Symptomatic Dengue Infection
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 3.9 Cases in 1000 person-years |
| Dengue 10-17Y Group | Incidence of All Laboratory-confirmed Symptomatic Dengue Infection | 14.1 Cases in 1000 person-years |
Secondary
Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 56.7 Cases in 1000 person-years |
| Dengue 10-17Y Group | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 66.6 Cases in 1000 person-years |
Secondary
Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 13.6 Cases in 1000 person-years |
| Dengue 10-17Y Group | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 33.1 Cases in 1000 person-years |
Secondary
Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 30.3 Cases in 1000 person-years |
| Dengue 10-17Y Group | Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection | 31.4 Cases in 1000 person-years |
Secondary
Number of Dengue Infection Cases by Virus Type (DENV)
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Dengue Infection Cases by Virus Type (DENV) | DENV-4, 2012 | 8 Dengue infection cases |
| Dengue 5-9Y Group | Number of Dengue Infection Cases by Virus Type (DENV) | DENV-4, 2013 | 6 Dengue infection cases |
| Dengue 5-9Y Group | Number of Dengue Infection Cases by Virus Type (DENV) | DENV-1, 2014 | 7 Dengue infection cases |
Secondary
Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature
Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.
Time frame: From Day 0 to Year 3
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature | 37.18 °C | Standard Deviation 0.952 |
Secondary
Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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
Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases
Length of hospitalization was part of the direct medical resource, associated with dengue infection.
Time frame: From Day 0 to Year 3
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases | 19.0 Days | Standard Deviation 0 |
Secondary
Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Abdominal pain | 17 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Headache | 43 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Retroorbital pain [eye pain] | 22 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Myalgia | 29 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Joint pain | 10 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Chills | 7 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Rash | 3 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Itching | 8 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | At least one digestive sign among first symptoms | 38 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Nausea or vomiting | 29 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Diarrhea | 10 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | At least one respiratory sign among first symptoms | 32 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Cough | 20 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Nasal congestion | 10 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Sore throat | 23 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Dyspnea | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | At least one hemorrhagic sign among first symptoms | 4 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Petechia | 3 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Purpura/ecchymosis | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Hematemesis [vomiting of blood] | 1 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Melena/hematochezia [blood in stool] | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Gingival bleeding | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Epistaxis | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Urinary tract bleeding | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Unusual vaginal bleeding | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | At least one other signs among first symptoms | 33 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Pallor or cool skin | 2 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Conjunctivis | 2 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Lethargy or restlessness | 3 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Dizziness | 11 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Thoracic pain | 0 dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms | Other | 28 dengue infection cases |
Secondary
Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 1, Positive | 12 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 1, Negative | 42 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 1, Missing confirmed | 3 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 1, Not applicable | 0 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 2, Positive | 4 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 2, Negative | 46 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 2, Missing confirmed | 3 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism | Primary care giver 2, Not applicable | 4 Dengue infection cases |
Secondary
Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | Positive | 49 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | Negative | 5 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | Missing confirmed | 3 Dengue infection cases |
| Dengue 5-9Y Group | Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism | Not applicable | 0 Dengue infection cases |
Secondary
Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 2 Dengue infection cases |
| Dengue 10-17Y Group | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 2 Dengue infection cases |
Secondary
Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 3 Dengue infection cases |
| Dengue 10-17Y Group | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 4 Dengue infection cases |
Secondary
Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 4 Dengue infection cases |
| Dengue 10-17Y Group | Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases | 8 Dengue infection cases |
Secondary
Number of School Days Missed by Subjects
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dengue 5-9Y Group | Number of School Days Missed by Subjects | 4.4 Days | Standard Deviation 2.58 |
Secondary
Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 4 Dengue infection cases |
| Dengue 10-17Y Group | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 13 Dengue infection cases |
Secondary
Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 0 Dengue infection cases |
| Dengue 10-17Y Group | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 10 Dengue infection cases |
Secondary
Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases
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)
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dengue 5-9Y Group | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 4 Dengue infection cases |
| Dengue 10-17Y Group | Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases | 3 Dengue infection cases |
Secondary
Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases
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
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
| Dengue 5-9Y Group | 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 |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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
Population: The analysis was performed on the Total cohort, which included all subjects enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dengue 5-9Y Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource
Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures
Time frame: From Day 0 to Year 3
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Subject hospitalized, positive | 2 Dengue infection cases |
| Dengue 5-9Y Group | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Subject hospitalized, negative | 54 Dengue infection cases |
| Dengue 5-9Y Group | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Subject hospitalized, unknown | 1 Dengue infection cases |
| Dengue 5-9Y Group | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Hospitalized in a study hospital, positive | 1 Dengue infection cases |
| Dengue 5-9Y Group | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Hospitalized in a study hospital, negative | 1 Dengue infection cases |
| Dengue 5-9Y Group | Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource | Hospitalized in a study hospital, unknown | 55 Dengue infection cases |
Secondary
Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dengue 5-9Y Group | 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
Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dengue 5-9Y Group | 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
Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment
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)
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 5 years old at enrollment | 32.57 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 6 years old at enrollment | 45.18 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 7 years old at enrollment | 38.86 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 8 years old at enrollment | 49.60 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 9 years old at enrollment | 50.20 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 10 years old at enrollment | 57.27 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 11 years old at enrollment | 68.87 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 12 years old at enrollment | 69.16 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, 13 years old at enrollment | 70.16 Proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment | IgG, Total | 54.08 Proportion of subjects |
Secondary
Proportion of Subjects With Primary Asymptomatic Dengue Infection
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
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dengue 5-9Y Group | Proportion of Subjects With Primary Asymptomatic Dengue Infection | Asymptomatic dengue, 2012 | 20.27 proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Primary Asymptomatic Dengue Infection | Asymptomatic dengue, 2013 | 8.70 proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Primary Asymptomatic Dengue Infection | Asymptomatic dengue, 2014 | 5.14 proportion of subjects |
| Dengue 5-9Y Group | Proportion of Subjects With Primary Asymptomatic Dengue Infection | Total | 13.09 proportion of subjects |