Not provided
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| Name | Class |
|---|---|
| Ministry of Health, Sri Lanka | OTHER_GOV |
The purpose of this study is to determine the incidence of dengue fever and to build capacity for dengue vaccine trials in dengue-endemic regions of South Asia.
This study aims to estimate the burden of dengue illness in selected sites South Asia and to prepare sites for the conduct of future vaccine efficacy trials.
Operational goals include:
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AFI Group | Experimental | Population living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years will be considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consent (and assent if applicable) to participate in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Procedure | Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever [body temperature ≥ 38°C/≥ 100.4°F] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD) OR date of last contact OR date of death. An AFI due to LCD was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°Celsius [C]/≥ 100.4°Farhenheit [F] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue through dengue Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F). | From first visit to last visit (approximatively 2 years per subject) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to non-LCD) OR date of last contact OR date of death. An AFI due to non-LCD was confirmed if all of the following criteria were met: Fever (body temperature ≥ 38°C/≥ 100.4°F) on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart, AND Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) was (valid but) negative for dengue. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Colombo | Sri Lanka |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34724624 | Derived | Tissera H, Samaraweera P, de Boer M, Gandhi S, Malvaux L, Mehta S, Palihawadana P, Vantomme V, Paris R, Schmidt A. The Burden of Acute Febrile Illness Attributable to Dengue Virus Infection in Sri Lanka: A Single-Center 2-Year Prospective Cohort Study (2016-2019). Am J Trop Med Hyg. 2021 Nov 1;106(1):160-167. doi: 10.4269/ajtmh.21-0604. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study. |
| 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 of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Dengue (LCD) Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD) OR date of last contact OR date of death. An AFI due to LCD was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°Celsius [C]/≥ 100.4°Farhenheit [F] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue through dengue Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F). | Analysis was performed on the Total cohort that included all subjects enrolled in the study. | Posted | Number | 95% Confidence Interval | Person-year rate ( Per 1000) | From first visit to last visit (approximatively 2 years per subject) |
Any signs or symptoms were collected during the 7-day period following the onset of fever. Serious adverse events were collected from first visit to last visit (approximately 2 years per subject).
The signs or symptoms collected were specified in the protocol and were not classified per MedDRA dictionary.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 877-379-3718 | GSKClinicalSupport@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2017 | Jun 16, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 21, 2019 | Jun 16, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From first visit to last visit (approximatively 2 years per subject) |
| Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 1) OR date of last contact OR date of death. An AFI due to LCD Sero Type 1 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 1 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F). | From first visit to last visit (approximatively 2 years per subject) |
| Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 2) OR date of last contact OR date of death. An AFI due to LCD Sero Type 2 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 2 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F). | From first visit to last visit (approximatively 2 years per subject) |
| Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 3) OR date of last contact OR date of death. An AFI due to LCD Sero Type 3 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 3 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) | From first visit to last visit (approximatively 2 years per subject) |
| Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 4) OR date of last contact OR date of death. An AFI due to LCD Sero Type 4 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 4 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) | From first visit to last visit (approximatively 2 years per subject) |
| Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. | Description of signs and symptoms of AFI due to LCD included the percentage of AFI presenting each sign or symptom (any intensity) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | At each day during the 7-day period following the onset of each episode of AFI due to LCD |
| Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD | Description of signs and symptoms of AFI due to LCD included the percentage of AFI presenting each sign or symptom (grade 3) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | At each day during the 7-day period following the onset of each episode of AFI due to LCD |
| Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD | Description of signs and symptoms of AFI due to non-LCD included the percentage of AFI presenting each sign or symptom (any intensity) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | At each day during the 7-day period following the onset of each episode of AFI due to non-LCD |
| Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD | Description of signs and symptoms of AFI due to non-LCD included the percentage of AFI presenting each sign or symptom (grade 3) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | At each day during the 7-day period following the onset of each episode of AFI due to non-LCD |
| 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 first visit to last visit (approximatively 2 years per subject) |
| 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 |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Study Group | Subjects aged between 6 months and 50 years at the time of enrollment, living in randomly selected households in geographically-defined communities. Households including at least one member aged less than 18 years were considered eligible if at least one adult (aged no more than 50 years) and one child (aged less than 18 years) consented (and assented if applicable) to participate in the study. |
|
|
| Secondary | Incidence Rate of Acute Febrile Illness (AFI) Due to Non-Laboratory Confirmed Dengue (Non-LCD) Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to non-LCD) OR date of last contact OR date of death. An AFI due to non-LCD was confirmed if all of the following criteria were met: Fever (body temperature ≥ 38°C/≥ 100.4°F) on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart, AND Dengue RT-qPCR result on the acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) was (valid but) negative for dengue. | Analysis was performed on the Total cohort that included all subjects enrolled in the study. | Posted | Number | 95% Confidence Interval | Events per 1000 person-year | From first visit to last visit (approximatively 2 years per subject) |
|
|
|
| Secondary | Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 1 Dengue Overall, and by Age Group. | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 1) OR date of last contact OR date of death. An AFI due to LCD Sero Type 1 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 1 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F). | Analysis was performed on the Total cohort that included all subjects enrolled in the study. | Posted | Number | 95% Confidence Interval | Events per 1000 person-year | From first visit to last visit (approximatively 2 years per subject) |
|
|
|
| Secondary | Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 2 Dengue Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 2) OR date of last contact OR date of death. An AFI due to LCD Sero Type 2 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 2 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F). | Analysis was performed on the Total cohort that included all subjects enrolled in the study. | Posted | Number | 95% Confidence Interval | Events per 1000 person-year | From first visit to last visit (approximatively 2 years per subject) |
|
|
|
| Secondary | Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 3 Dengue Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 3) OR date of last contact OR date of death. An AFI due to LCD Sero Type 3 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 3 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) | Analysis was performed on the Total cohort that included all subjects enrolled in the study | Posted | Number | 95% Confidence Interval | Events per 1000 person-year | From first visit to last visit (approximatively 2 years per subject) |
|
|
|
| Secondary | Incidence Rate of Acute Febrile Illness (AFI) Due to Laboratory Confirmed Sero Type 4 Dengue Overall, and by Age Group | The incidence rate of first event (IR per 1000 person-years) was calculated by dividing the number of subjects reporting at least one episode of event during the follow-up period by the total person-year at risk. The person-time at risk for an event of interest was calculated as the duration between the date of enrolment and the end of the at-risk period or the earliest of the following: onset date of event of interest (e.g. first episode of AFI due to LCD Sero Type 4) OR date of last contact OR date of death. An AFI due to LCD Sero Type 4 was confirmed if all of the following criteria were met: Fever (body temperature greater than or equal to (≥) 38°C/≥ 100.4°F on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart AND Laboratory confirmation of dengue Sero Type 4 through RT-qPCR on acute serum sample taken during the 7-day period (Days 2-7) from the onset of fever (body temperature ≥ 38°C/≥ 100.4°F) | Analysis was performed on the Total cohort that included all subjects enrolled in the study. | Posted | Number | 95% Confidence Interval | Events per 1000 person-year | From first visit to last visit (approximatively 2 years per subject) |
|
|
|
| Secondary | Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD. | Description of signs and symptoms of AFI due to LCD included the percentage of AFI presenting each sign or symptom (any intensity) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | Analysis was performed on all subjects enrolled in the study and with AFI due to LCD. | Posted | Count of Units | AFI episodes | At each day during the 7-day period following the onset of each episode of AFI due to LCD | AFI episodes | AFI episodes |
|
|
|
| Secondary | Number of Acute Febrile Illness Due to Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to LCD | Description of signs and symptoms of AFI due to LCD included the percentage of AFI presenting each sign or symptom (grade 3) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | Analysis was performed on all subjects enrolled in the study and with AFI due to LCD. | Posted | Count of Units | AFI episodes | At each day during the 7-day period following the onset of each episode of AFI due to LCD | AFI episodes | AFI episodes |
|
|
|
| Secondary | Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Any Intensity) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD | Description of signs and symptoms of AFI due to non-LCD included the percentage of AFI presenting each sign or symptom (any intensity) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | Analysis was performed on all subjects enrolled in the study and with AFI due to non-LCD. | Posted | Count of Units | AFI episodes | At each day during the 7-day period following the onset of each episode of AFI due to non-LCD | AFI episodes | AFI episodes |
|
|
|
| Secondary | Number of Acute Febrile Illness Due to Non-Laboratory Confirmed Dengue Presenting a Sign or a Symptom of Interest (Grade 3) During the 7-day Period Following the Onset of Each Episode of AFI Due to Non-LCD | Description of signs and symptoms of AFI due to non-LCD included the percentage of AFI presenting each sign or symptom (grade 3) during the 7-day period from the onset of fever (body temperature 38°C/100.4°F). | Analysis was performed on all subjects enrolled in the study and with AFI due to non-LCD. | Posted | Count of Units | AFI episodes | At each day during the 7-day period following the onset of each episode of AFI due to non-LCD | AFI episodes | AFI episodes |
|
|
|
| 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 first visit to last visit (approximatively 2 years per subject) |
|
|
|
| 0 |
| 2,004 |
| 0 |
| 2,004 |
| 216 |
| 2,004 |
| Arthralgia | General disorders | Systematic Assessment |
|
| Bleeding | General disorders | Systematic Assessment |
|
| Eye pain | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Loss of appetite | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Rash | General disorders | Systematic Assessment |
|
| Reduced fluid intake | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
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 |
|
| 12 to 17 years |
|
|
| ≥ 18 years |
|
|
| Overall |
|
|
|
| 12 to 17 years |
|
|
| ≥ 18 |
|
|
| Overall |
|
|
|
| 12 to 17 years |
|
|
| ≥ 18 years |
|
|
| Overall |
|
|
|
| 12 to 17 years |
|
|
| ≥ 18 |
|
|
| Overall |
|
|
|
| 12 to 17 years |
|
|
| ≥ 18 |
|
|
| Overall |
|
|
| Title | Measurements |
|---|---|
|
| Headache / irritability at Day 4 |
|
| Headache / irritability at Day 5 |
|
| Headache / irritability at Day 6 |
|
| Headache / irritability at Day 7 |
|
| Eye pain at Day 1 |
|
| Eye pain at Day 2 |
|
| Eye pain at Day 3 |
|
| Eye pain at Day 4 |
|
| Eye pain at Day 5 |
|
| Eye pain at Day 6 |
|
| Eye pain at Day 7 |
|
| Myalgia (muscle pain) at Day 1 |
|
| Myalgia (muscle pain) at Day 2 |
|
| Myalgia (muscle pain) at Day 3 |
|
| Myalgia (muscle pain) at Day 4 |
|
| Myalgia (muscle pain) at Day 5 |
|
| Myalgia (muscle pain) at Day 6 |
|
| Myalgia (muscle pain) at Day 7 |
|
| Arthralgia (joint pain) at Day 1 |
|
| Arthralgia (joint pain) at Day 2 |
|
| Arthralgia (joint pain) at Day 3 |
|
| Arthralgia (joint pain) at Day 4 |
|
| Arthralgia (joint pain) at Day 5 |
|
| Arthralgia (joint pain) at Day 6 |
|
| Arthralgia (joint pain) at Day 7 |
|
| Abdominal pain at Day 1 |
|
| Abdominal pain at Day 2 |
|
| Abdominal pain at Day 3 |
|
| Abdominal pain at Day 4 |
|
| Abdominal pain at Day 5 |
|
| Abdominal pain at Day 6 |
|
| Abdominal pain at Day 7 |
|
| Nausea at Day 1 |
|
| Nausea at Day 2 |
|
| Nausea at Day 3 |
|
| Nausea at Day 4 |
|
| Nausea at Day 5 |
|
| Nausea at Day 6 |
|
| Nausea at Day 7 |
|
| Vomiting at Day 1 |
|
| Vomiting at Day 2 |
|
| Vomiting at Day 3 |
|
| Vomiting at Day 4 |
|
| Vomiting at Day 5 |
|
| Vomiting at Day 6 |
|
| Vomiting at Day 7 |
|
| Rash at Day 1 |
|
| Rash at Day 2 |
|
| Rash at Day 3 |
|
| Rash at Day 4 |
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| Rash at Day 5 |
|
| Rash at Day 6 |
|
| Rash at Day 7 |
|
| Any bleeding (skin, mouth, anus) at Day 1 |
|
| Any bleeding (skin, mouth, anus) at Day 2 |
|
| Any bleeding (skin, mouth, anus) at Day 3 |
|
| Any bleeding (skin, mouth, anus) at Day 4 |
|
| Any bleeding (skin, mouth, anus) at Day 5 |
|
| Any bleeding (skin, mouth, anus) at Day 6 |
|
| Any bleeding (skin, mouth, anus) at Day 7 |
|
| Loss of appetite at Day 1 |
|
| Loss of appetite at Day 2 |
|
| Loss of appetite at Day 3 |
|
| Loss of appetite at Day 4 |
|
| Loss of appetite at Day 5 |
|
| Loss of appetite at Day 6 |
|
| Loss of appetite at Day 7 |
|
| Fatigue/decrease in normal activity at Day 1 |
|
| Fatigue/decrease in normal activity at Day 2 |
|
| Fatigue/decrease in normal activity at Day 3 |
|
| Fatigue/decrease in normal activity at Day 4 |
|
| Fatigue/decrease in normal activity at Day 5 |
|
| Fatigue/decrease in normal activity at Day 6 |
|
| Fatigue/decrease in normal activity at Day 7 |
|
| Reduced fluid intake at Day 1 |
|
| Reduced fluid intake at Day 2 |
|
| Reduced fluid intake at Day 3 |
|
| Reduced fluid intake at Day 4 |
|
| Reduced fluid intake at Day 5 |
|
| Reduced fluid intake at Day 6 |
|
| Reduced fluid intake at Day 7 |
|
| Title | Measurements |
|---|---|
|
| Headache / irritability at Day 4 |
|
| Headache / irritability at Day 5 |
|
| Headache / irritability at Day 6 |
|
| Headache / irritability at Day 7 |
|
| Eye pain at Day 1 |
|
| Eye pain at Day 2 |
|
| Eye pain at Day 3 |
|
| Eye pain at Day 4 |
|
| Eye pain at Day 5 |
|
| Eye pain at Day 6 |
|
| Eye pain at Day 7 |
|
| Myalgia (muscle pain) at Day 1 |
|
| Myalgia (muscle pain) at Day 2 |
|
| Myalgia (muscle pain) at Day 3 |
|
| Myalgia (muscle pain) at Day 4 |
|
| Myalgia (muscle pain) at Day 5 |
|
| Myalgia (muscle pain) at Day 6 |
|
| Myalgia (muscle pain) at Day 7 |
|
| Arthralgia (joint pain) at Day 1 |
|
| Arthralgia (joint pain) at Day 2 |
|
| Arthralgia (joint pain) at Day 3 |
|
| Arthralgia (joint pain) at Day 4 |
|
| Arthralgia (joint pain) at Day 5 |
|
| Arthralgia (joint pain) at Day 6 |
|
| Arthralgia (joint pain) at Day 7 |
|
| Abdominal pain at Day 1 |
|
| Abdominal pain at Day 2 |
|
| Abdominal pain at Day 3 |
|
| Abdominal pain at Day 4 |
|
| Abdominal pain at Day 5 |
|
| Abdominal pain at Day 6 |
|
| Abdominal pain at Day 7 |
|
| Vomiting at Day 1 |
|
| Vomiting at Day 2 |
|
| Vomiting at Day 3 |
|
| Vomiting at Day 4 |
|
| Vomiting at Day 5 |
|
| Vomiting at Day 6 |
|
| Vomiting at Day 7 |
|
| Rash at Day 1 |
|
| Rash at Day 2 |
|
| Rash at Day 3 |
|
| Rash at Day 4 |
|
| Rash at Day 5 |
|
| Rash at Day 6 |
|
| Rash at Day 7 |
|
| Loss of appetite at Day 1 |
|
| Loss of appetite at Day 2 |
|
| Loss of appetite at Day 3 |
|
| Loss of appetite at Day 4 |
|
| Loss of appetite at Day 5 |
|
| Loss of appetite at Day 6 |
|
| Loss of appetite at Day 7 |
|
| Fatigue/decrease in normal activity at Day 1 |
|
| Fatigue/decrease in normal activity at Day 2 |
|
| Fatigue/decrease in normal activity at Day 3 |
|
| Fatigue/decrease in normal activity at Day 4 |
|
| Fatigue/decrease in normal activity at Day 5 |
|
| Fatigue/decrease in normal activity at Day 6 |
|
| Fatigue/decrease in normal activity at Day 7 |
|
| Reduced fluid intake at Day 1 |
|
| Reduced fluid intake at Day 2 |
|
| Reduced fluid intake at Day 3 |
|
| Reduced fluid intake at Day 4 |
|
| Reduced fluid intake at Day 5 |
|
| Reduced fluid intake at Day 6 |
|
| Reduced fluid intake at Day 7 |
|
| Title | Measurements |
|---|---|
|
| Headache / irritability at Day 4 |
|
| Headache / irritability at Day 5 |
|
| Headache / irritability at Day 6 |
|
| Headache / irritability at Day 7 |
|
| Eye pain at Day 1 |
|
| Eye pain at Day 2 |
|
| Eye pain at Day 3 |
|
| Eye pain at Day 4 |
|
| Eye pain at Day 5 |
|
| Eye pain at Day 6 |
|
| Eye pain at Day 7 |
|
| Myalgia (muscle pain) at Day 1 |
|
| Myalgia (muscle pain) at Day 2 |
|
| Myalgia (muscle pain) at Day 3 |
|
| Myalgia (muscle pain) at Day 4 |
|
| Myalgia (muscle pain) at Day 5 |
|
| Myalgia (muscle pain) at Day 6 |
|
| Myalgia (muscle pain) at Day 7 |
|
| Arthralgia (joint pain at Day 1 |
|
| Arthralgia (joint pain at Day 2 |
|
| Arthralgia (joint pain at Day 3 |
|
| Arthralgia (joint pain at Day 4 |
|
| Arthralgia (joint pain at Day 5 |
|
| Arthralgia (joint pain at Day 6 |
|
| Arthralgia (joint pain at Day 7 |
|
| Abdominal pain at Day 1 |
|
| Abdominal pain at Day 2 |
|
| Abdominal pain at Day 3 |
|
| Abdominal pain at Day 4 |
|
| Abdominal pain at Day 5 |
|
| Abdominal pain at Day 6 |
|
| Abdominal pain at Day 7 |
|
| Nausea at Day 1 |
|
| Nausea at Day 2 |
|
| Nausea at Day 3 |
|
| Nausea at Day 4 |
|
| Nausea at Day 5 |
|
| Nausea at Day 6 |
|
| Nausea at Day 7 |
|
| Vomiting at Day 1 |
|
| Vomiting at Day 2 |
|
| Vomiting at Day 3 |
|
| Vomiting at Day 4 |
|
| Vomiting at Day 5 |
|
| Vomiting at Day 6 |
|
| Vomiting at Day 7 |
|
| Rash at Day 1 |
|
| Rash at Day 2 |
|
| Rash at Day 3 |
|
| Rash at Day 4 |
|
| Rash at Day 5 |
|
| Rash at Day 6 |
|
| Rash at Day 7 |
|
| Any bleeding (skin, mouth, anus) at Day 1 |
|
| Any bleeding (skin, mouth, anus) at Day 2 |
|
| Any bleeding (skin, mouth, anus) at Day 3 |
|
| Any bleeding (skin, mouth, anus) at Day 4 |
|
| Any bleeding (skin, mouth, anus) at Day 5 |
|
| Any bleeding (skin, mouth, anus) at Day 6 |
|
| Any bleeding (skin, mouth, anus) at Day 7 |
|
| Loss of appetite at Day 1 |
|
| Loss of appetite at Day 2 |
|
| Loss of appetite at Day 3 |
|
| Loss of appetite at Day 4 |
|
| Loss of appetite at Day 5 |
|
| Loss of appetite at Day 6 |
|
| Loss of appetite at Day 7 |
|
| Fatigue/decrease in normal activity at Day 1 |
|
| Fatigue/decrease in normal activity at Day 2 |
|
| Fatigue/decrease in normal activity at Day 3 |
|
| Fatigue/decrease in normal activity at Day 4 |
|
| Fatigue/decrease in normal activity at Day 5 |
|
| Fatigue/decrease in normal activity at Day 6 |
|
| Fatigue/decrease in normal activity at Day 7 |
|
| Reduced fluid intake at Day 1 |
|
| Reduced fluid intake at Day 2 |
|
| Reduced fluid intake at Day 3 |
|
| Reduced fluid intake at Day 4 |
|
| Reduced fluid intake at Day 5 |
|
| Reduced fluid intake at Day 6 |
|
| Reduced fluid intake at Day 7 |
|
| Title | Measurements |
|---|---|
|
| Headache / irritability at Day 4 |
|
| Headache / irritability at Day 5 |
|
| Headache / irritability at Day 6 |
|
| Headache / irritability at Day 7 |
|
| Eye pain at Day 1 |
|
| Eye pain at Day 2 |
|
| Eye pain at Day 3 |
|
| Eye pain at Day 4 |
|
| Eye pain at Day 5 |
|
| Eye pain at Day 6 |
|
| Eye pain at Day 7 |
|
| Myalgia (muscle pain) at Day 1 |
|
| Myalgia (muscle pain) at Day 2 |
|
| Myalgia (muscle pain) at Day 3 |
|
| Myalgia (muscle pain) at Day 4 |
|
| Myalgia (muscle pain) at Day 5 |
|
| Myalgia (muscle pain) at Day 6 |
|
| Myalgia (muscle pain) at Day 7 |
|
| Arthralgia (joint pain) at Day 1 |
|
| Arthralgia (joint pain) at Day 2 |
|
| Arthralgia (joint pain) at Day 3 |
|
| Arthralgia (joint pain) at Day 4 |
|
| Arthralgia (joint pain) at Day 5 |
|
| Arthralgia (joint pain) at Day 6 |
|
| Arthralgia (joint pain) at Day 7 |
|
| Abdominal pain at Day 1 |
|
| Abdominal pain at Day 2 |
|
| Abdominal pain at Day 3 |
|
| Abdominal pain at Day 4 |
|
| Abdominal pain at Day 5 |
|
| Abdominal pain at Day 6 |
|
| Abdominal pain at Day 7 |
|
| Nausea at Day 1 |
|
| Nausea at Day 2 |
|
| Nausea at Day 3 |
|
| Nausea at Day 4 |
|
| Nausea at Day 5 |
|
| Nausea at Day 6 |
|
| Nausea at Day 7 |
|
| Vomiting at Day 1 |
|
| Vomiting at Day 2 |
|
| Vomiting at Day 3 |
|
| Vomiting at Day 4 |
|
| Vomiting at Day 5 |
|
| Vomiting at Day 6 |
|
| Vomiting at Day 7 |
|
| Rash at Day 1 |
|
| Rash at Day 2 |
|
| Rash at Day 3 |
|
| Rash at Day 4 |
|
| Rash at Day 5 |
|
| Rash at Day 6 |
|
| Rash at Day 7 |
|
| Loss of appetite at Day 1 |
|
| Loss of appetite at Day 2 |
|
| Loss of appetite at Day 3 |
|
| Loss of appetite at Day 4 |
|
| Loss of appetite at Day 5 |
|
| Loss of appetite at Day 6 |
|
| Loss of appetite at Day 7 |
|
| Fatigue/decrease in normal activity at Day 1 |
|
| Fatigue/decrease in normal activity at Day 2 |
|
| Fatigue/decrease in normal activity at Day 3 |
|
| Fatigue/decrease in normal activity at Day 4 |
|
| Fatigue/decrease in normal activity at Day 5 |
|
| Fatigue/decrease in normal activity at Day 6 |
|
| Fatigue/decrease in normal activity at Day 7 |
|
| Reduced fluid intake at Day 1 |
|
| Reduced fluid intake at Day 2 |
|
| Reduced fluid intake at Day 3 |
|
| Reduced fluid intake at Day 4 |
|
| Reduced fluid intake at Day 5 |
|
| Reduced fluid intake at Day 6 |
|
| Reduced fluid intake at Day 7 |
|