0.5 mL, Subcutaneous at Day 0, 6 and 12 months, respectively

An AE was any untoward medical occurrence in a participant administered study vaccine and which does not necessarily have a causal relationship. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Hospitalized VCD cases were defined as an acute febrile illness with diagnosis of dengue requiring hospitalization. The confirmatory dengue diagnosis was performed through virological detection.

The percentage of participants with detected and quantified CYD dengue vaccinal viremia, i.e above the detection level as assessed by reverse transcription-polymerase chain reaction (RT-PCR) and for each of the 4 dengue serotypes after the first CYD dengue vaccine injection has been reported. Four RT-PCRs were used to perform quantitation and serotype identification of post-vaccinal serotype-specific dengue vaccine viremia from serum samples displaying a positive yellow fever (YF) RT-PCR result. The assay was performed only for YT RT-PCR-positive samples.

A decrease in CD4 count greater than 30 % assessed 28 days post-injection compared to the pre-injection value, not explained by non-adherence to antiretroviral therapy (ART) and not explained by any other possible etiology, and confirmed by a second test taken 4 weeks after the first (ie, approximately 2 months post-injection) showing the same value/trend.

A confirmed HIV viral load increase was defined as plasma HIV-1 RNA >1000 copies/milliliter (mL) 28 days post-injection after having been undetectable (< 50 copies/mL) pre-injection, not explained by non-adherence to ART and not explained by any other possible etiology and confirmed by a second test taken 4 weeks after the first (i.e, approximately 2 months post-injection) showing the same value/trend.

Total of all reporting groups

Race and Ethnicity were not collected from any participant.

Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.

An AE was any untoward medical occurrence in a participant administered study vaccine and which did not necessarily have a causal relationship. A solicited reaction was an expected adverse reaction (AR) observed and reported under the conditions pre-listed in the protocol and CRF and included pain, erythema, and swelling. Injection site reaction was an AR at and around the injection site. Injection site reactions were commonly inflammatory reactions.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected. Only those participants with data available were analyzed.

A solicited reaction was an "expected" adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. Solicited systemic reactions included headache, fever, localized or topical manifestations that were not associated with the vaccination or administration site.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.

An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the protocol and CRF in terms of diagnosis and/or onset window post-vaccination. An AESI was one of scientific and medical concern specific to the study vaccine, for which ongoing monitoring, and rapid communication by the Investigator to the Sponsor was appropriate. The following were considered as serious AESI: serious hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination; serious viscerotropic disease occurring in all participants within 30 days after vaccination; serious neurotropic disease occurring in all participants within 30 days after vaccination; serious dengue disease requiring hospitalization occurring in all participants at any time during the study. The following were considered as non-serious AESIs, hypersensitivity/allergic reactions occurring in all participants within 7 days after vaccination.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.

An AE was any untoward medical occurrence in a participant administered study vaccine and which does not necessarily have a causal relationship. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Hospitalized VCD cases were defined as an acute febrile illness with diagnosis of dengue requiring hospitalization. The confirmatory dengue diagnosis was performed through virological detection.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.

Dengue neutralizing antibody levels were measured by PRNT50. Serial, 2-fold dilutions of serum to be tested (previously heat-inactivated) were mixed with a constant challenge-dose of each dengue virus serotype 1, 2, 3 or 4. The presence of dengue virus infected cells was indicated by formation of plaques. A reduction in virus infectivity due to neutralization by antibody present in serum samples was detected. The reported value represented the highest dilution of serum at which >= 50% of dengue challenge virus (in plaque counts) was neutralized when compared to the mean viral plaque count in the negative control wells which represented the 100% virus load.

The Full analysis set consisted of participants who received either CYD dengue vaccine or placebo and had blood sample drawn and valid post-injection serology results. Only data from the participants analyzed were reported.

The percentage of participants with detected and quantified CYD dengue vaccinal viremia, i.e above the detection level as assessed by reverse transcription-polymerase chain reaction (RT-PCR) and for each of the 4 dengue serotypes after the first CYD dengue vaccine injection has been reported. Four RT-PCRs were used to perform quantitation and serotype identification of post-vaccinal serotype-specific dengue vaccine viremia from serum samples displaying a positive yellow fever (YF) RT-PCR result. The assay was performed only for YT RT-PCR-positive samples.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected. Only data from the participants analyzed were reported.

A decrease in CD4 count greater than 30 % assessed 28 days post-injection compared to the pre-injection value, not explained by non-adherence to antiretroviral therapy (ART) and not explained by any other possible etiology, and confirmed by a second test taken 4 weeks after the first (ie, approximately 2 months post-injection) showing the same value/trend.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected. Only those participants with data available were analyzed.

A confirmed HIV viral load increase was defined as plasma HIV-1 RNA >1000 copies/milliliter (mL) 28 days post-injection after having been undetectable (< 50 copies/mL) pre-injection, not explained by non-adherence to ART and not explained by any other possible etiology and confirmed by a second test taken 4 weeks after the first (i.e, approximately 2 months post-injection) showing the same value/trend.

The SafAS population consisted of participants who had received study vaccine and for which safety data were scheduled to be collected.

Participants were administered a single dose of SC injection of placebo vaccine each on Day 0, 6 months and 12 months.