Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue, Dengue fever, CYD dengue vaccine, IXIARO JE vaccine, Flavivirus
Brief summary
The aim of the study was to evaluate a compressed dosing schedule and the immunologic effects of co-administration of a CYD dengue vaccine with a licensed flavivirus (FV) with Japanese encephalitis (JE) vaccine. Primary Objectives: * To describe and compare the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose. * To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 after CYD dengue vaccine Dose 3, irrespective of whether or not JE vaccine had been previously administered. Secondary Objectives: * To describe the safety profile after each injection of CYD dengue vaccine. * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each CYD dengue vaccine dose when administered with or after JE virus vaccine in Groups 3 and 4. * To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes at 6 months post-dose 3 in all four groups and at 12 months post-dose 3 in Groups 1 and 3 with the compressed schedule. * To determine the level of viremia on Day (D)0, D3, D5, D7 and D14 following each CYD vaccine dose administered in Groups 1-4. * To describe the JE humoral immune response at baseline and 28 days after each injection of CYD dengue vaccine in Groups 3 and 4.
Detailed description
Study participants were randomly assigned to one of the four groups to receive assigned study vaccine and were evaluated for neutralizing antibody titers; markers of cell-mediated immunity.
Interventions
0.5 mL, Subcutaneous
0.5 mL, Intramuscular
Sponsors
Study design
Eligibility
Inclusion criteria
* Aged greater than or equal to (\>=)18 to less than or equal to (\<=) 45 years on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and complied with all trial procedures. * Participant was in good health, based on medical history and physical examination.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female had to be post- menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination). * Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt or planned receipt of any vaccine, outside the study protocol in the 4 weeks preceded or followed trial vaccinations. (If influenza activity warranted vaccination of healthy young adults, influenza vaccination was encouraged and did not lead to study exclusion). * Any history of FV vaccination, or planned FV vaccination during the trial period. * Previous residence (greater than \[\>\]12 months) in, or travel in the last 30 days to dengue endemic regions. * Receipt of immune globulins, blood or blood-derived products in the 3 months prior to first vaccination or planned use during the study period. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceded 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known systemic hypersensitivity to any of the vaccine components (including protamine sulfate), or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including dry natural latex. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Excessive alcohol consumption or drug addiction. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion. * Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator. * Temporary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3 | GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution). |
| Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3 | Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | 6 months and 12 months post-injection 3 | GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. |
| Number of Participants With Detectable Serotype-Specific Vaccine Viremia | 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3 | Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes. |
| Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3, 5, 7 and 14 days post-injection 1, 2 and 3 | Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine. |
| Number of Participants With Solicited Injection Site Reactions | Within 7 days after any CYD dengue vaccine and/or JE vaccine | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling. |
| Number of Participants With Solicited Systemic Reactions | Within 14 days after any CYD dengue vaccine and/or JE vaccine | A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia. |
| Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | Pre-injection 1, and 28 days post-injection 1, 2 and 3 | GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution). |
| Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3 | GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution). |
Countries
United States
Participant flow
Recruitment details
Participants were involved in the study from 05 November 2013 to 25 November 2015 in the United States.
Pre-assignment details
A total of 90 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine: Group 1 Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, respectively. | 25 |
| CYD Dengue Vaccine: Group 2 Participants received 3 doses of CYD dengue vaccine, one each at 0, 6 and 12 months, respectively. | 15 |
| CYD Dengue and JE Vaccine : Group 3 Participants received 3 doses of CYD dengue vaccine, one each at 0, 2 and 6 months, and 2 doses of JE (IXIARO) vaccine at 0 and 1 months, respectively. | 25 |
| CYD Dengue and JE Vaccine: Group 4 Participants received 2 doses of JE (IXIARO) vaccine at 0 and 1 months; and 3 doses of CYD dengue vaccine at 7, 9 and 13 months, respectively. | 25 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 3 | 12 | 8 |
| Overall Study | Other than specified above | 0 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine: Group 1 | CYD Dengue Vaccine: Group 2 | CYD Dengue and JE Vaccine : Group 3 | CYD Dengue and JE Vaccine: Group 4 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 31.0 years STANDARD_DEVIATION 6.7 | 26.8 years STANDARD_DEVIATION 5.6 | 28.5 years STANDARD_DEVIATION 6.5 | 30.4 years STANDARD_DEVIATION 6.2 | 29.4 years STANDARD_DEVIATION 6.4 |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 7 Participants | 12 Participants | 37 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 18 Participants | 13 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 15 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 18 / 25 | 15 / 15 | 17 / 25 | 20 / 25 |
| serious Total, serious adverse events | 3 / 25 | 0 / 15 | 0 / 25 | 1 / 25 |
Outcome results
Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).
Time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Population: Analysis was performed on full analysis set which included participants who received at least one injection of CYD dengue vaccine or JE vaccine and had at least one blood sample drawn and valid post-injection serology result. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 120.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 22.1 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 7.1 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 19.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 24.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 31.0 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 45.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 22.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 9.1 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 108.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 5.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 105.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 6.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 166.6 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 9.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 12.1 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 296.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 19.0 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 13.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 8.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 425.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 32.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 13.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 6.1 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 124.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 33.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 669.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 24.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 25.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 9.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 7.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 15.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 6.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 79.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 5.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 40.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 100.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 6.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 9.6 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 31.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 5.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 89.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 106.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 9.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 7.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 6.6 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 10.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 147.1 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 28.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 6.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 6.7 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 10.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 8.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 12.0 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 8.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 8.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 8.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 17.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 12.2 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 19.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 10.9 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | 5.2 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 19.7 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 23.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 20.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 32.2 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 19.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 177.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 89.9 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 68.0 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 47.7 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 55.4 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 43.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 21.0 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 48.2 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 7.2 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 37.4 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 61.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 92.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 325.4 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 44.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 35.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 152.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 300.9 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 7.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 7.4 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 211.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 12.9 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 6.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 35.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 68.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 49.0 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 139.5 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 61.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 49.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 10.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 24.8 titers (1/dilution) |
Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains
Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Time frame: Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3
Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 16 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 15 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 3 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 10 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 11 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 12 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 14 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 12 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 5 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 17 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 2 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 15 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 3 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 17 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 5 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 5 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 21 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 9 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 8 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 6 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 21 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 12 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 7 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 3 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 12 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 9 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 13 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 7 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 9 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 4 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 7 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 12 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 1 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 9 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 13 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 7 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 10 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 1 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 12 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 11 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 6 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 3 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 5 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 13 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 10 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 3 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 2 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 5 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 3 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 5 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 2 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 4 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 4 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 7 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 7 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 9 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 4 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 10 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 10 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 9 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 9 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 6 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 16 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 11 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 11 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 11 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 11 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 7 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 9 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 3 | 15 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 2 | 4 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 3 | 13 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 2 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 14 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 1 | 18 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 2 | 15 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: 28 days Post-injection 1 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 3 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 2 | 18 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 2: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 4 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 1 | 6 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: 28 days Post-injection 2 | 18 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 3 | 9 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 3 | 3 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 3 | 12 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 2 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 2 | 14 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 4: Pre-injection 3 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 3 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 28 days Post-injection 1 | 16 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: Pre-injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 1: 28 days Post-injection 2 | 8 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 10 Participants |
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.
Time frame: 6 months and 12 months post-injection 3
Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category. Data was not planned to be collected and analyzed for Groups 2 and 4 for 12 months post-injection 3 time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 19.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 5.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 105.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 12 months Post-injection 3 | 144.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 12 months Post-injection 3 | 18.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 13.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 12 months Post-injection 3 | 11.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 12 months Post-injection 3 | 5.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 7.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 6.6 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 33.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 106.7 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 19.3 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 12 months Post-injection 3 | 23.9 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 43.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 10.9 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 12 months Post-injection 3 | 7.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 12 months Post-injection 3 | 16.2 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 8.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine : Group 3 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 12 months Post-injection 3 | 7.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 4: 6 months Post-injection 3 | 92.6 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 2: 6 months Post-injection 3 | 21.0 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 3: 6 months Post-injection 3 | 24.8 titers (1/dilution) |
| CYD Dengue and JE Vaccine: Group 4 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains | Serotype 1: 6 months Post-injection 3 | 7.3 titers (1/dilution) |
Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4
GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution).
Time frame: Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3
Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: 28 days Post-injection 1 | 6.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: Pre-injection 2 | 6.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: 28 days Post-injection 2 | 10.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: Pre-injection 3 | 8.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: 28 days Post-injection 3 | 12.0 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: 28 days Post-injection 1 | 8.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: Pre-injection 2 | 8.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: 28 days Post-injection 2 | 17.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: Pre-injection 3 | 12.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: 28 days Post-injection 3 | 19.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: Pre-injection 1 | 5.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: 28 days Post-injection 1 | 19.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: Pre-injection 2 | 23.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: 28 days Post-injection 2 | 28.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: Pre-injection 3 | 20.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: 28 days Post-injection 3 | 32.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: 28 days Post-injection 1 | 177.6 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: Pre-injection 2 | 89.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: 28 days Post-injection 2 | 68.0 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: Pre-injection 3 | 47.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: 28 days Post-injection 3 | 55.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: Pre-injection 3 | 139.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: 28 days Post-injection 1 | 7.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: Pre-injection 2 | 7.2 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: 28 days Post-injection 1 | 49.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: 28 days Post-injection 2 | 10.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: 28 days Post-injection 2 | 211.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: Pre-injection 3 | 6.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: Pre-injection 2 | 49.0 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 1: 28 days Post-injection 3 | 12.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: 28 days Post-injection 1 | 325.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: 28 days Post-injection 2 | 68.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: 28 days Post-injection 1 | 35.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: 28 days Post-injection 3 | 152.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: Pre-injection 2 | 44.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: Pre-injection 3 | 35.6 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: 28 days Post-injection 2 | 61.5 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 4: Pre-injection 2 | 300.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: Pre-injection 3 | 37.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 3: 28 days Post-injection 3 | 61.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4 | Serotype 2: 28 days Post-injection 3 | 48.2 titers (1/dilution) |
Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4
GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution).
Time frame: Pre-injection 1, and 28 days post-injection 1, 2 and 3
Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | Pre-injection 1 | NA titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | 28 days Post-injection 1 | 132.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | 28 days Post-injection 2 | 382.7 titers (1/dilution) |
| CYD Dengue Vaccine: Group 1 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | 28 days Post-injection 3 | 82.3 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | 28 days Post-injection 3 | 157.4 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | Pre-injection 1 | 22.9 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | 28 days Post-injection 2 | 501.8 titers (1/dilution) |
| CYD Dengue Vaccine: Group 2 | Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4 | 28 days Post-injection 1 | 620.9 titers (1/dilution) |
Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia
Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine.
Time frame: 3, 5, 7 and 14 days post-injection 1, 2 and 3
Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 2 | 1 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 1 | 16 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 1 | 12 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 1 | 7 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 3 | 1 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 1 | 5 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 1 | 4 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 2 | 1 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 1 | 9 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 1 | 8 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 1 | 3 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 2 | 1 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 1 | 6 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 1 | 9 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 3 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 7 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 5 days Post-Injection 1 | 3 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia | 3 days Post-Injection 3 | 0 Participants |
Number of Participants With Detectable Serotype-Specific Vaccine Viremia
Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes.
Time frame: 3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3
Population: Analysis was performed on full analysis set. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 7 days Post-Injection 3 | 1 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 5 days Post-Injection 1 | 6 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 7 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 7 days Post-Injection 1 | 13 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 7 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 14 days Post-Injection 1 | 8 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 5 days Post-Injection 1 | 2 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 7 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 7 days Post-Injection 1 | 2 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 14 days Post-Injection 1 | 1 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 7 days Post-Injection 3 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 5 days Post-Injection 1 | 1 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 7 days Post-Injection 1 | 5 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 14 days Post-Injection 1 | 1 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 7 days Post-Injection 1 | 7 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 7 days Post-Injection 1 | 1 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 14 days Post-Injection 1 | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 14 days Post-Injection 2 | 0 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 7 days Post-Injection 1 | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 5 days Post-Injection 1 | 3 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 7 days Post-Injection 1 | 1 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 14 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 7 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 7 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 5 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 7 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 7 days Post-Injection 1 | 5 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 14 days Post-Injection 1 | 2 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 7 days Post-Injection 1 | 7 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 7 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 3 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 7 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 14 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 2: 3 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 5 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 7 days Post-Injection 1 | 4 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 14 days Post-Injection 1 | 1 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 3: 3 days Post-Injection 2 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 5 days Post-Injection 1 | 2 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 1: 3 days Post-Injection 1 | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 14 days Post-Injection 1 | 4 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Detectable Serotype-Specific Vaccine Viremia | Serotype 4: 3 days Post-Injection 2 | 0 Participants |
Number of Participants With Solicited Injection Site Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling.
Time frame: Within 7 days after any CYD dengue vaccine and/or JE vaccine
Population: Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Injection Site Reactions | Injection site Pain | 7 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Injection Site Reactions | Injection site Swelling | 3 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Injection Site Reactions | Injection site Erythema | 7 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Injection Site Reactions | Injection site Pain | 6 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Injection Site Reactions | Injection site Swelling | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Injection Site Reactions | Injection site Erythema | 4 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Injection Site Reactions | Injection site Erythema | 2 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Injection Site Reactions | Injection site Pain | 3 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Injection Site Reactions | Injection site Swelling | 0 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Injection Site Reactions | Injection site Pain | 6 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Injection Site Reactions | Injection site Swelling | 1 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Injection Site Reactions | Injection site Erythema | 2 Participants |
Number of Participants With Solicited Systemic Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia.
Time frame: Within 14 days after any CYD dengue vaccine and/or JE vaccine
Population: Analysis was performed on safety analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Systemic Reactions | Myalgia | 8 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Systemic Reactions | Headache | 10 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Systemic Reactions | Asthenia | 6 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Systemic Reactions | Malaise | 9 Participants |
| CYD Dengue Vaccine: Group 1 | Number of Participants With Solicited Systemic Reactions | Fever | 2 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Systemic Reactions | Malaise | 10 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Systemic Reactions | Myalgia | 6 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Systemic Reactions | Asthenia | 7 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Systemic Reactions | Headache | 11 Participants |
| CYD Dengue Vaccine: Group 2 | Number of Participants With Solicited Systemic Reactions | Fever | 2 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Systemic Reactions | Malaise | 11 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Systemic Reactions | Fever | 3 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Systemic Reactions | Headache | 12 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Systemic Reactions | Myalgia | 10 Participants |
| CYD Dengue and JE Vaccine : Group 3 | Number of Participants With Solicited Systemic Reactions | Asthenia | 7 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Systemic Reactions | Myalgia | 7 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Systemic Reactions | Headache | 11 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Systemic Reactions | Fever | 1 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Systemic Reactions | Malaise | 6 Participants |
| CYD Dengue and JE Vaccine: Group 4 | Number of Participants With Solicited Systemic Reactions | Asthenia | 3 Participants |