This Study Will Describe the Burden of DENgue Fever Virus (DENV) Illness Among Household Members Aged 6 Months to 50 Years of Selected Communities in Latin America and Southeast Asia

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)

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.

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)

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects from the Philippines, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.

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)

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.

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)

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.

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)

Population: No data was collected by DENV-type due to the low number of cases reported, therefore no analysis could be performed.

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)

Population: Analysis was performed on the Total cohort that included all subjects enrolled in the study.

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)

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol, for whom data of at least one follow-up contact were available and who were defined as suspected dengue cases.

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)

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol, for whom data of at least one follow-up contact were available and who were defined as suspected dengue cases.

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

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects from Mexico (1-4 years age) and the Philippines (6-12 months), i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.

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

Population: Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.