An interventional study of Blood sample collection in Dengue and Dengue Vaccines, sponsored by GlaxoSmithKline. Terminated at 2 sites in 2 countries. Open to participants aged 6 Months to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Other
The purpose of this study is to describe the burden of DENV illness among household members aged 6 months to 50 years of selected communities in Latin America and Southeast Asia.
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 1,750 is above the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects aged between 6 months and 50 years at the time of enrolment living in geographically-defined communities in Latin America and Southeast Asia. The study population comprised household members and should include between 30% and 50% of adults (aged 18 years or above) per site.The appropriate recruitment strategy was selected by each participating site. Two approaches might be considered: a school-based approach and a community-based approach without school involvement The expected period for recruiting the target sample size was approximately three months.
Procedure: Blood sample collection
All participants will have an enrolment visit with collection of a blood sample and a termination contact/visit. Participants or their parents/guardians will be contacted weekly or every two weeks to monitor the occurrence of febrile episodes. Additional visits will be made if febrile episodes occur. In case of dengue suspicion, a blood sample will be collected.
Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site
Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
Time frame: From Day 0 to Month 24 (study end)
Number of Subjects With DENV-type Specific Confirmed Symptomatic DENV Infection
Dengue Virus (DENV)-Type 1, 2 3 or 4 Ribonucleid acid would have been considered for this analysis but it was not performed due to the low number of cases reported.
Time frame: From Day 0 to Month 24 (study end)
Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico
Incidence proportion of virologically confirmed symptomatic dengue infection was estimated from GEE logistic regression model taking the clustering effect into account. The 95% confidence interval was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Virologically confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR or non-structural protein 1 (NS1). See SDC definition in outcome 5.
Time frame: From Day 0 to Month 24 (study end)
Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.
Incidence percentage of virologically confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
Time frame: From Day 0 to Month 24 (study end)
Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.
Incidence proportion of probable confirmed symptomatic dengue infection was estimated from GEE model with clustering effect. Clusters were households for analysis by study site and study sites for analysis on overall study sites. A probable confirmed dengue infection is an SDC with DENV RT-qPCR negative or not performed (late presenter), and DENV NS1 negative or undetermined (early or late presenter), and Anti-DENV Immunoglobulin type M (IgM) positive with a rapid immunochromatographic (ICT) assay or an Enzyme-linked Immunosorbent Assay (ELISA) assay, or Anti-DENV IgG positive (rapid ICT assay or 'capture ELISA' assay). SDC defined as acute febrile illness measured as greater or equal to 38.0°C or recent history of febrile illness (onset in the past 8 days) reported for at least 2 consecutive days (duration of approximately 36-48 hours) and \< 7 days duration, which might be accompanied by other dengue symptoms or signs with no defined focus or obvious reason unrelated to dengue.
Time frame: From Day 0 to Month 24 (study end)
Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
The proportion of subjects with Dengue Virus antibody IgG positive result (ELISA) was estimated from GEE model with clustering effect. The 95% CI was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately, as there were no probable cases reported in the study.
Time frame: At Day 0
Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.
The percentage of subjects with Dengue Virus antibody IgG positive result (ELISA) was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately as there were no probable cases reported in the study.
Time frame: At Day 0
Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits
The following characteristics were summarized for each category of dengue cases (Virologically confirmed, probable, other SDC): Temperature at first visit: \<37.5, ≥37.5, \>38, \>38.5, \>39 °C and Clinical symptoms at onset, from first and returned visits. The results are presented for the virologically confirmed cases (VDC) and the other SDC (oSDC), no probable cases being reported in the study.
Time frame: From Day 0 to Month 24 (study end)
Number of Suspected Dengue Cases With Severity Criteria Characteristics
The clinical classification of the suspected dengue cases were distributed among following categories: Subject hospitalized during suspected dengue episode; OR At least 1 WHO 2009 warning signs: i.e. Abdominal pain or tenderness, Persistent vomiting, Clinical fluid accumulation, Mucosal bleed, Liver enlargement, Increase in HCT concurrent with rapid decrease in platelet count, Lethargy and restlessness; OR At least 1 WHO 2009 criteria for severe dengue: i.e. Severe Plasma Leakage leading to Shock, Fluid accumulation with respiratory distress, Severe Bleeding, Severe organ involvement; Liver: Aspartate transaminase or Alanine transferase ≥ 1000 International Unit/Liter, Central nervous system: impaired consciousness, Failure of heart and other organs; OR Most likely diagnosis for an episode of defined illnesses \[investigator opinion\]. The following characteristics were summarized for Virologically confirmed cases (VDC) and other SDC (oSDC), no probable cases being reported.
Time frame: From Day 0 to Month 24 (study end)
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 or is a congenital anomaly/birth defect in the offspring of a study subject..
Time frame: From Day 0 to Month 24 (study end)
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. Hence, only 2 sites participated to the study, 1 in Mexico and 1 in Philippines.
| Milestone | Total Group |
|---|---|
| Started | 850 |
| Completed | 344 |
| Not completed | 506 |
| Withdrew: Sponsor study termination | 498 |
| Withdrew: Migrated/moved from the study area | 1 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Other | 1 |
| Withdrew: Death | 1 |
Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period \]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
| Percentage of subjects | Total Group |
|---|---|
| Mexico | 1.1 (0.4 to 3.0) |
| Philippines | 0.8 (0.3 to 2.1) |
Dengue Virus (DENV)-Type 1, 2 3 or 4 Ribonucleid acid would have been considered for this analysis but it was not performed due to the low number of cases reported.
No measurements were reported for this outcome.
Incidence proportion of virologically confirmed symptomatic dengue infection was estimated from GEE logistic regression model taking the clustering effect into account. The 95% confidence interval was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Virologically confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR or non-structural protein 1 (NS1). See SDC definition in outcome 5.
| Proportion of subjects | Total Group |
|---|---|
| Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico | 1.4 (0.5 to 3.8) |
Incidence percentage of virologically confirmed symptomatic dengue infection was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.
| Percentage of subjects | Total Group |
|---|---|
| Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines. | 0.8 (0.3 to 2.1) |
Incidence proportion of probable confirmed symptomatic dengue infection was estimated from GEE model with clustering effect. Clusters were households for analysis by study site and study sites for analysis on overall study sites. A probable confirmed dengue infection is an SDC with DENV RT-qPCR negative or not performed (late presenter), and DENV NS1 negative or undetermined (early or late presenter), and Anti-DENV Immunoglobulin type M (IgM) positive with a rapid immunochromatographic (ICT) assay or an Enzyme-linked Immunosorbent Assay (ELISA) assay, or Anti-DENV IgG positive (rapid ICT assay or 'capture ELISA' assay). SDC defined as acute febrile illness measured as greater or equal to 38.0°C or recent history of febrile illness (onset in the past 8 days) reported for at least 2 consecutive days (duration of approximately 36-48 hours) and \< 7 days duration, which might be accompanied by other dengue symptoms or signs with no defined focus or obvious reason unrelated to dengue.
| Proportion of subjects | Total Group |
|---|---|
| Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period. | 0 (NA to NA) |
The proportion of subjects with Dengue Virus antibody IgG positive result (ELISA) was estimated from GEE model with clustering effect. The 95% CI was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately, as there were no probable cases reported in the study.
| Proportion of subjects | Total Group |
|---|---|
| Mexico- 6 months -12 months | 0 (NA to NA) |
| Mexico- 5-8 years | 11.8 (4.5 to 27.5) |
| Mexico- 9-17 years | 16.6 (9.8 to 26.6) |
| Mexico- 18-50 years | 27.2 (19.8 to 36.2) |
| Philippines- 1-4 years | 31.2 (21.7 to 42.7) |
| Philippines- 5-8 years | 51.5 (40.8 to 62.0) |
| Philippines- 9-17 years | 92.0 (86.4 to 95.4) |
| Philippines- 18-50 years | 99.3 (95.4 to 99.9) |
The percentage of subjects with Dengue Virus antibody IgG positive result (ELISA) was expressed as percentage of subjects = (n \[number of subjects with at least one event reported during the study period\]/N \[number of subjects in the population\]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. Ages categories were defined as follows: "6 months -\<12 Months" = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next "n-p Years" categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately as there were no probable cases reported in the study.
| Percentage of subjects | Total Group |
|---|---|
| Mexico- 1-4 years | 6.4 (2.1 to 18.0) |
| Philippines- 6 months -12 months | 8.3 (1.2 to 41.3) |
The following characteristics were summarized for each category of dengue cases (Virologically confirmed, probable, other SDC): Temperature at first visit: \<37.5, ≥37.5, \>38, \>38.5, \>39 °C and Clinical symptoms at onset, from first and returned visits. The results are presented for the virologically confirmed cases (VDC) and the other SDC (oSDC), no probable cases being reported in the study.
| Participants | Total Group |
|---|---|
| Temperature <37.5 °C VDC | 5 |
| Temperature ≥37.5 °C VDC | 4 |
| Temperature >38.0 °C VDC | 4 |
| Temperature >38.5 °C VDC | 1 |
| Temperature >39.0 °C VDC | 0 |
| At least one main sign VDC | 9 |
| Fever VDC | 9 |
| Headache VDC | 7 |
| Retroorbital pain [eye pain] VDC | 6 |
| Myalgia VDC | 5 |
| Join pain VDC | 3 |
| Chills VDC | 2 |
| Rash VDC | 1 |
| Itching VDC | 1 |
| At least one digestive symptom VDC | 5 |
| Abdominal pain VDC | 5 |
| Nausea or vomiting VDC | 4 |
| Diarrhea VDC | 2 |
| At least one respiratory symptom VDC | 5 |
| Cough VDC | 4 |
| Nasal Congestion VDC | 2 |
| Sore throat VDC | 1 |
| Dyspnea VDC | 0 |
| At least one hemorrhagic manifestation VDC | 1 |
| Petechia VDC | 1 |
| Purpura/ecchymosis VDC | 0 |
| Hematemesis [vomiting of blood] VDC | 0 |
| Melena/hematochezia [blood in stool] VDC | 0 |
| Gingival bleeding VDC | 0 |
| Epistaxis VDC | 0 |
| Urinary tract bleeding VDC | 0 |
| Unusual vaginal bleeding VDC | 0 |
| At least one other signs VDC | 6 |
| Pallor or cool skin VDC | 0 |
| Conjunctivis VDC | 1 |
| Jaundice VDC | 0 |
| Convulsion or coma VDC | 0 |
| Lethargy or restlessness VDC | 0 |
| Clinical fluid accumulation VDC | 1 |
| Dizziness VDC | 1 |
| Thoracic pain VDC | 0 |
| Other VDC | 6 |
| Temperature <37.5 °C oSDC | 15 |
| Temperature ≥37.5 °C oSDC | 3 |
| Temperature >38.0 °C oSDC | 2 |
| Temperature >38.5 °C oSDC | 0 |
| Temperature >39.0 °C oSDC | 0 |
| At least one main sign oSDC | 18 |
| Fever oSDC | 18 |
| Headache oSDC | 15 |
| Retroorbital pain [eye pain] oSDC | 9 |
| Myalgia oSDC | 11 |
| Join pain oSDC | 8 |
| Chills oSDC | 2 |
| Rash oSDC | 4 |
| Itching oSDC | 1 |
| At least one digestive symptom oSDC | 12 |
| Abdominal pain oSDC | 8 |
| Nausea or vomiting oSDC | 11 |
| Diarrhea oSDC | 2 |
| At least one respiratory symptom oSDC | 11 |
| Cough oSDC | 8 |
| Nasal Congestion oSDC | 6 |
| Sore throat oSDC | 2 |
| Dyspnea oSDC | 1 |
| At least one hemorrhagic manifestation oSDC | 1 |
| Petechia oSDC | 0 |
| Purpura/ecchymosis oSDC | 0 |
| Hematemesis [vomiting of blood] oSDC | 0 |
| Melena/hematochezia [blood in stool] oSDC | 0 |
| Gingival bleeding oSDC | 1 |
| Epistaxis oSDC | 1 |
| Urinary tract bleeding oSDC | 0 |
| Unusual vaginal bleeding oSDC | 0 |
| At least one other signs oSDC | 10 |
| Pallor or cool skin oSDC | 0 |
| Conjunctivis oSDC | 1 |
| Jaundice oSDC | 0 |
| Convulsion or coma oSDC | 0 |
| Lethargy or restlessness oSDC | 2 |
| Clinical fluid accumulation oSDC | 0 |
| Dizziness oSDC | 2 |
| Thoracic pain oSDC | 0 |
| Other oSDC | 7 |
The clinical classification of the suspected dengue cases were distributed among following categories: Subject hospitalized during suspected dengue episode; OR At least 1 WHO 2009 warning signs: i.e. Abdominal pain or tenderness, Persistent vomiting, Clinical fluid accumulation, Mucosal bleed, Liver enlargement, Increase in HCT concurrent with rapid decrease in platelet count, Lethargy and restlessness; OR At least 1 WHO 2009 criteria for severe dengue: i.e. Severe Plasma Leakage leading to Shock, Fluid accumulation with respiratory distress, Severe Bleeding, Severe organ involvement; Liver: Aspartate transaminase or Alanine transferase ≥ 1000 International Unit/Liter, Central nervous system: impaired consciousness, Failure of heart and other organs; OR Most likely diagnosis for an episode of defined illnesses \[investigator opinion\]. The following characteristics were summarized for Virologically confirmed cases (VDC) and other SDC (oSDC), no probable cases being reported.
| Participants | Total Group |
|---|---|
| Subject hospitalized VDC | 0 |
| At least 1 WHO 2009 warning signs VDC | 5 |
| At least 1 WHO 2009 severe dengue criteria VDC | 0 |
| Most likely diagnosis: Dengue VDC | 7 |
| Most likely diagnosis: Chikungunya VDC | 0 |
| Most likely diagnosis: Influenza VDC | 0 |
| Most likely diagnosis: Malaria VDC | 0 |
| Most likely diagnosis: Leptospirosis VDC | 0 |
| Most likely diagnosis: Rota/enteric infection VDC | 0 |
| Most likely diagnosis: other infection disease VDC | 2 |
| Most likely diagnosis: non-infectious disease VDC | 0 |
| Subject hospitalized oSDC | 0 |
| At least 1 WHO 2009 warning signs oSDC | 1 |
| At least 1 WHO 2009 severe dengue criteria oSDC | 0 |
| Most likely diagnosis: Dengue oSDC | 2 |
| Most likely diagnosis: Chikungunya oSDC | 0 |
| Most likely diagnosis: Influenza oSDC | 2 |
| Most likely diagnosis: Malaria oSDC | 0 |
| Most likely diagnosis: Leptospirosis oSDC | 0 |
| Most likely diagnosis: Rota/enteric infection oSDC | 0 |
| Most likely diagnosis: other infection oSDC | 18 |
| Most likely diagnosis: non-infectious disease oSDC | 0 |
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 or is a congenital anomaly/birth defect in the offspring of a study subject..
| Participants | Total Group |
|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure | 0 |
Collected over Serious adverse events were collected from Day 0 to Month 24 (study end).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Group | 1/850 (0.1%) | 0/850 (0%) | — |
| Age, Continuous(years) | Total Group |
|---|---|
| Mean | 17.4 ± 13.38 |
| Sex: Female, Male(Participants) | Total Group |
|---|---|
| Female | 456 |
| Male | 394 |
| Race and Ethnicity Not Collected(Participants) | Total Group |
|---|
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline