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| Name | Class |
|---|---|
| Tropical Disease Foundation | OTHER |
| Goncalo Moniz Research Center | OTHER |
| Evandro Chagas Research Institute, Bio-Manguinhos Technology and Immunology Institute | OTHER_GOV |
The purpose of this study is to estimate the incidence of dengue infection in children and adults in geographically distinct locations of Brazil.
The aim of this study is to generate dengue disease burden data including estimates of incidence rates, prevalence data and the clinical presentation of dengue across different age groups.
The study will be conducted in at least three cities: Rio de Janeiro, Salvador, and Manaus. This study will also prepare potential sites for future clinical trials, by setting up the logistics and training staff on site to enroll a cohort of subjects perform dengue surveillance and other study procedures.
Households will be randomly selected from communities where a registry system is implemented. All individuals in the household will be eligible for participating in the study. This study will be sponsored by GSK and co-funded by GSK and Fiocruz. As study sponsor, GSK will delegate some activities to Fiocruz, according to the provisions in their Cooperative Research and Development Agreement (CRADA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Group | Other | Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | Blood samples will be collected at each study visit (Day 0, Month 6, Month 12, Month 24, Month 36 and Month 48) 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 infection diagnosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year | Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year | Incidence rate (IR) of virologically-confirmed symptomatic dengue infection with 95% Confidence Interval (CI) for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all virologically-confirmed dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. A virologically confirmed symptomatic dengue infection is defined as a dengue case confirmed by RT-qPCR. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Manaus | Amazonas | 69040000 | Brazil | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33894353 | Derived | de Aguiar DF, de Barros ENC, Ribeiro GS, Brasil P, Mourao MPG, Luz K, Aoki FH, Freitas ARR, Calvet GA, Oliveira E, Branco BF, Abreu A, Cheuvart B, Guignard A, de Boer M, Duarte AC, Borges MB, de Noronha TG. A prospective, multicentre, cohort study to assess the incidence of dengue illness in households from selected communities in Brazil (2014-2018). Int J Infect Dis. 2021 Jul;108:443-453. doi: 10.1016/j.ijid.2021.04.062. Epub 2021 Apr 21. |
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In December 2017, GSK decided to deprioritize the development of the dengue purified inactivated vaccine (DPIV) candidate. This decision was made due to the significant scientific challenges of dengue vaccine development.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Group | Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Group | Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year | Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
Serious adverse events related to study procedure were collected from Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject).
Other adverse events were not collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Total Group | Subjects six months of age and older at the time of enrolment, recruited from randomly selected households originating from preselected mapped communities. Preferably the recruitment period occurred outside of the peak dengue transmission season, and continued until each site had reached its foreseen target. The expected period for recruiting the target sample size was approximately three months. Recruitment of replacement subjects was done during the low dengue transmission and the recruitment period depended on the number of subjects that need to be replaced. Enrolled subjects were subjects who either lived in households in study areas with support from the Family Health Physician Program (FHP) or the Larval Index Rapid Assay (LIRA) or with field research experience in the community (preferred) or where a similar system of mapped communities with potential for surveillance existed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 435-7343 | 866 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2017 | Jan 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 29, 2019 | Jan 27, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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|
| Data collection | Other | Diary logs will be issued to all subjects at every visit, except Month 48 (Day 0, Month 6, Month 12, Month 24, and Month 36), as required. Any completed diary logs will be verified, as applicable. Subjects will be given a diary log in the event of the occurrence of a symptom that may be associated with suspected dengue. |
|
| At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year | Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by study site, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year | Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by age category, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year | Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by gender, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases | A primary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and without evidence of previous dengue infection (absence of Ig G antibodies at the previous scheduled visit and absence of laboratory confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported. | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
| Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases | A secondary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and with evidence of previous dengue infection (presence of IgG antibodies at the previous scheduled visit(s) or laboratory-confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported. | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
| Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall | A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline). | At the first visit of the first year |
| Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender | A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline). | At the first visit of the first year |
| Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment | A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline). | At the first visit of the first year |
| Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit | Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by site and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit | Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by age category and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit | Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by gender and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
| Number of Suspected Dengue Cases With Severity Criteria | To describe symptoms and spectrum of dengue disease in the study population for the suspected dengue cases, excluding those reported without fever. Suspected symptomatic dengue case= Febrile illness with body temperature ≥ 38°C measured (by any route) on at least two consecutive days and less than 14 days with or without the presence of other dengue symptoms or signs, without an obvious aetiology unrelated to dengue, based on investigator's judgement; Lab-confirmed = laboratory-confirmed symptomatic dengue cases; Probable = probable symptomatic dengue cases; Negative = negative symptomatic dengue cases; Indeterminate = indeterminate symptomatic dengue case( not classified as laboratory confirmed case, probable case or negative case); Severe dengue episode = at least one criteria met for severe dengue (in accordance to the "dengue with warning signs" and "severe dengue" definitions in the 2009 WHO guidelines for dengue). | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
| Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
| Salvador |
| Estado de Bahia |
| Brazil |
| GSK Investigational Site | Natal | Rio Grande do Norte | 59025-050 | Brazil |
| GSK Investigational Site | Campinas | São Paulo | Brazil |
| GSK Investigational Site | Rio de Janeiro | 21040-900 | Brazil |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Death |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year | Incidence rate (IR) of virologically-confirmed symptomatic dengue infection with 95% Confidence Interval (CI) for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all virologically-confirmed dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. A virologically confirmed symptomatic dengue infection is defined as a dengue case confirmed by RT-qPCR. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year | Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by study site, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year | Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by age category, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year | Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by gender, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
|
|
|
| Secondary | Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases | A primary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and without evidence of previous dengue infection (absence of Ig G antibodies at the previous scheduled visit and absence of laboratory confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported. | Analysis was performed on the laboratory confirmed or probable symptomatic dengue cases, excluding those reported without fever or reported before the first visit in the first year. | Posted | Count of Participants | Participants | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
|
|
|
| Secondary | Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases | A secondary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and with evidence of previous dengue infection (presence of IgG antibodies at the previous scheduled visit(s) or laboratory-confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported. | Analysis was performed on the laboratory confirmed or probable symptomatic dengue cases, excluding those reported without fever or reported before the first visit in the first year. | Posted | Count of Participants | Participants | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
|
|
|
| Secondary | Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall | A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline). | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Count of Participants | Participants | At the first visit of the first year |
|
|
|
| Secondary | Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender | A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline). | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Count of Participants | Participants | At the first visit of the first year |
|
|
|
| Secondary | Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment | A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline). | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year. | Posted | Count of Participants | Participants | At the first visit of the first year |
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit | Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by site and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit | Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by age category and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
|
|
|
| Secondary | Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit | Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by gender and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year. | Posted | Number | 95% Confidence Interval | infections per 1000 person-year | At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years |
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|
|
| Secondary | Number of Suspected Dengue Cases With Severity Criteria | To describe symptoms and spectrum of dengue disease in the study population for the suspected dengue cases, excluding those reported without fever. Suspected symptomatic dengue case= Febrile illness with body temperature ≥ 38°C measured (by any route) on at least two consecutive days and less than 14 days with or without the presence of other dengue symptoms or signs, without an obvious aetiology unrelated to dengue, based on investigator's judgement; Lab-confirmed = laboratory-confirmed symptomatic dengue cases; Probable = probable symptomatic dengue cases; Negative = negative symptomatic dengue cases; Indeterminate = indeterminate symptomatic dengue case( not classified as laboratory confirmed case, probable case or negative case); Severe dengue episode = at least one criteria met for severe dengue (in accordance to the "dengue with warning signs" and "severe dengue" definitions in the 2009 WHO guidelines for dengue). | Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who were defined as suspected dengue cases, excluding those without fever or reported before the first visit. | Posted | Count of Participants | Participants | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Analysis was performed on the Total cohort that included all subjects enrolled in the study. | Posted | Count of Participants | Participants | From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject) |
|
|
|
| 31 |
| 3,300 |
| 0 |
| 3,300 |
| 0 |
| 0 |
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.
| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Year 2016 |
|
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| Year 2017 |
|
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| Year 2018 |
|
|
| Overall calendar years |
|
|
|
| Rio at year 2016 |
|
|
| Rio at year 2017 |
|
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| Rio at year 2018 |
|
|
| Rio overall calendar years |
|
|
| Manaus at year 2014 |
|
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| Manaus at year 2015 |
|
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| Manaus at year 2016 |
|
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| Manaus at year 2017 |
|
|
| Manaus at year 2018 |
|
|
| Manaus overall calendar years |
|
|
| Salvador at year 2015 |
|
|
| Salvador at year 2016 |
|
|
| Salvador at year 2017 |
|
|
| Salvador at year 2018 |
|
|
| Salvador overall calendar years |
|
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| Natal at year 2016 |
|
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| Natal at year 2017 |
|
|
| Natal at year 2018 |
|
|
| Natal overall calendar years |
|
|
| Campinas at year 2017 |
|
|
| Campinas at year 2018 |
|
|
| Campinas overall calendar years |
|
|
| All study sites at year 2014 |
|
|
| All study sites at year 2015 |
|
|
| All study sites at year 2016 |
|
|
| All study sites at year 2017 |
|
|
| All study sites at year 2018 |
|
|
| All study sites overall calendar years |
|
|
|
| ≤17 years at year 2016 |
|
|
| ≤17 years at year 2017 |
|
|
| ≤17 years at year 2018 |
|
|
| ≤17 years overall calendar years |
|
|
| 18-49 years at year 2014 |
|
|
| 18-49 years at year 2015 |
|
|
| 18-49 years at year 2016 |
|
|
| 18-49 years at year 2017 |
|
|
| 18-49 years at year 2018 |
|
|
| 18-49 years overall calendar years |
|
|
| ≥ 50 years at year 2014 |
|
|
| ≥ 50 years at year 2015 |
|
|
| ≥ 50 years at year 2016 |
|
|
| ≥ 50 years at year 2017 |
|
|
| ≥ 50 years at year 2018 |
|
|
| ≥ 50 years overall calendar years |
|
|
|
| Female at year 2016 |
|
|
| Female at year 2017 |
|
|
| Female at year 2018 |
|
|
| Female overall calendar years |
|
|
| Male at year 2014 |
|
|
| Male at year 2015 |
|
|
| Male at year 2016 |
|
|
| Male at year 2017 |
|
|
| Male at year 2018 |
|
|
| Male overall calendar years |
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|
|
| Primary symptomatic cases in Salvador |
|
|
| Primary symptomatic cases in Natal |
|
|
| Primary symptomatic cases in Campinas |
|
|
| Overall primary symptomatic cases |
|
|
|
| Secondary symptomatic cases in Salvador |
|
|
| Secondary symptomatic cases in Natal |
|
|
| Secondary symptomatic cases in Campinas |
|
|
| Overall secondary symptomatic cases |
|
|
|
| Seroprevalence at visit 1 in Salvador |
|
|
| Seroprevalence at visit 1 in Natal |
|
|
| Seroprevalence at visit 1 in Campinas |
|
|
| Overall seroprevalence at visit 1 |
|
|
|
| Seroprevalence at visit 1 in Salvador-females |
|
|
| Seroprevalence at visit 1 in Natal-females |
|
|
| Seroprevalence at visit 1 in Campinas-females |
|
|
| Overall seroprevalence at visit 1-females |
|
|
| Seroprevalence at visit 1 in Rio-males |
|
|
| Seroprevalence at visit 1 in Manaus-males |
|
|
| Seroprevalence at visit 1 in Salvador-males |
|
|
| Seroprevalence at visit 1 in Natal-males |
|
|
| Seroprevalence at visit 1 in Campinas-males |
|
|
| Overall seroprevalence at visit 1-males |
|
|
|
| First seroprevalence at ≤17 years in Salvador |
|
|
| First seroprevalence at ≤17 years in Natal |
|
|
| First seroprevalence at ≤17 years in Campinas |
|
|
| Overall first seroprevalence at ≤17 years |
|
|
| First seroprevalence at 18-49 years in Rio |
|
|
| First seroprevalence at 18-49 years in Manaus |
|
|
| First seroprevalence at 18-49 years in Salvador |
|
|
| First seroprevalence at 18-49 years in Natal |
|
|
| First seroprevalence at 18-49 years in Campinas |
|
|
| Overall first seroprevalence at 18-49 years |
|
|
| First seroprevalence at ≥50 years in Rio |
|
|
| First seroprevalence at ≥50 years in Manaus |
|
|
| First seroprevalence at ≥50 years in Salvador |
|
|
| First seroprevalence at ≥50 years in Natal |
|
|
| First seroprevalence at ≥50 years in Campinas |
|
|
| Overall first seroprevalence at ≥50 years |
|
|
|
| Primary inapparent dengue in Rio at year 2016 |
|
|
| Primary inapparent dengue in Rio at year 2017 |
|
|
| Primary inapparent dengue in Rio at year 2018 |
|
|
| Overall primary inapparent dengue in Rio |
|
|
| Primary inapparent dengue in Manuas at year 2014 |
|
|
| Primary inapparent dengue in Manuas at year 2015 |
|
|
| Primary inapparent dengue in Manuas at year 2016 |
|
|
| Primary inapparent dengue in Manuas at year 2017 |
|
|
| Primary inapparent dengue in Manuas at year 2018 |
|
|
| Overall primary inapparent dengue in Manuas |
|
|
| Primary inapparent dengue in Salvador at year 2015 |
|
|
| Primary inapparent dengue in Salvador at year 2016 |
|
|
| Primary inapparent dengue in Salvador at year 2017 |
|
|
| Primary inapparent dengue in Salvador at year 2018 |
|
|
| Overall primary inapparent dengue in Salvador |
|
|
| Primary inapparent dengue in Natal at year 2016 |
|
|
| Primary inapparent dengue in Natal at year 2017 |
|
|
| Primary inapparent dengue in Natal at year 2018 |
|
|
| Overall primary inapparent dengue in Natal |
|
|
| Primary inapparent dengue in Campinas at year 2017 |
|
|
| Primary inapparent dengue in Campinas at year 2018 |
|
|
| Overall primary inapparent dengue in Campinas |
|
|
| Overall primary inapparent dengue in 2014 |
|
|
| Overall primary inapparent dengue in 2015 |
|
|
| Overall primary inapparent dengue in 2016 |
|
|
| Overall primary inapparent dengue in 2017 |
|
|
| Overall primary inapparent dengue in 2018 |
|
|
| Overall primary inapparent dengue overall years |
|
|
|
| Primary inapparent dengue at ≤17 years in 2016 |
|
|
| Primary inapparent dengue at ≤17 years in 2017 |
|
|
| Primary inapparent dengue at ≤17 years in 2018 |
|
|
| Overall primary inapparent dengue at ≤17 years |
|
|
| Primary inapparent dengue at 18-49 years in 2014 |
|
|
| Primary inapparent dengue at 18-49 years in 2015 |
|
|
| Primary inapparent dengue at 18-49 years in 2016 |
|
|
| Primary inapparent dengue at 18-49 years in 2017 |
|
|
| Primary inapparent dengue at 18-49 years in 2018 |
|
|
| Overall primary inapparent dengue at 18-49 years |
|
|
| Primary inapparent dengue at ≥ 50 years in 2014 |
|
|
| Primary inapparent dengue at ≥ 50 years in 2015 |
|
|
| Primary inapparent dengue at ≥ 50 years in 2016 |
|
|
| Primary inapparent dengue at ≥ 50 years in 2017 |
|
|
| Primary inapparent dengue at ≥ 50 years in 2018 |
|
|
| Overall primary inapparent dengue at ≥ 50 years |
|
|
|
| Primary inapparent dengue at year 2016- females |
|
|
| Primary inapparent dengue at year 2017- females |
|
|
| Primary inapparent dengue at year 2018- females |
|
|
| Overall Primary inapparent dengue- females |
|
|
| Primary inapparent dengue at year 2014- males |
|
|
| Primary inapparent dengue at year 2015- males |
|
|
| Primary inapparent dengue at year 2016- males |
|
|
| Primary inapparent dengue at year 2017- males |
|
|
| Primary inapparent dengue at year 2018- males |
|
|
| Overall primary inapparent dengue- males |
|
|
|
| Severe dengue episode- negative |
|
|
| Severe dengue episode- probable |
|
|
| Severe dengue episode- total |
|
|
| Severe plasma leakage- indeterminate |
|
|
| Severe plasma leakage- lab-confirmed |
|
|
| Severe plasma leakage- negative |
|
|
| Severe plasma leakage- probable |
|
|
| Severe plasma leakage- total |
|
|
| Fluid accumulation- indeterminate |
|
|
| Fluid accumulation- lab-confirmed |
|
|
| Fluid accumulation- negative |
|
|
| Fluid accumulation- probable |
|
|
| Fluid accumulation- total |
|
|
| Severe bleeding- indeterminate |
|
|
| Severe bleeding- lab-confirmed |
|
|
| Severe bleeding- negative |
|
|
| Severe bleeding- probable |
|
|
| Severe bleeding- total |
|
|
| Liver involvement- indeterminate |
|
|
| Liver involvement- lab-confirmed |
|
|
| Liver involvement- negative |
|
|
| Liver involvement- probable |
|
|
| Liver involvement- total |
|
|
| Central Nervous System involvement- indeterminate |
|
|
| Central Nervous System involvement- lab-confirmed |
|
|
| Central Nervous System involvement- negative |
|
|
| Central Nervous System involvement- probable |
|
|
| Central Nervous System involvement- total |
|
|
| Heart and other organs involvement- indeterminate |
|
|
| Heart and other organs involvement- lab-confirmed |
|
|
| Heart and other organs involvement- negative |
|
|
| Heart and other organs involvement- probable |
|
|
| Heart and other organs involvement- total |
|
|