Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
Conditions
Keywords
Dengue fever, Dengue hemorrhagic fever, Dengue virus
Brief summary
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formulations of tetravalent dengue vaccine administered at Month 0 and Month 6. The secondary objectives were: * To evaluate the safety of the 3 formulations of tetravalent CYD dengue vaccine. * To describe the neutralizing antibody responses to each of the 3 vaccine formulations. * To describe vaccine viremia after the first and second dose of each of the 3 vaccine formulations in a subset of participants.
Detailed description
All participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group. Safety was assessed in all participants as follows: solicited adverse event (AE) prelisted in the diary card were collected for 7 days after vaccination for solicited injection site reactions and 14 days for solicited systemic reactions , unsolicited AEs were collected for 28 days after vaccination, and serious adverse event (SAE) information collected throughout the study up to 6 months after vaccination.
Interventions
BIOLOGICALTetravalent CYD Dengue Vaccine , 5555 formulation
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively.
BIOLOGICALTetravalent CYD Dengue Vaccine , 5553 formulation
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
BIOLOGICALTetravalent CYD Dengue Vaccine, 4444 formulation
A 0.5 mL dose, Subcutaneous at 0, 6, and 12 months, respectively
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, as determined by medical history, clinical examination, and biological safety parameters. * Aged 18 to 45 years on the day of inclusion. * Provision of informed consent signed by the participant or another legally acceptable representative. * For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination. * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test. * Breast-feeding woman. * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed. * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances. * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator. * Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures. * Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations. * Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening. * Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening. * Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity. * Reported history of flavivirus infection as reported by the participant. * Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever). * Flavivirus vaccination planned during the trial period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7) | Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13) | Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. |
| Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13) | Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. In this outcome measure, participants with antibody titers \>= 10 1/dil against any 1 of the 4 serotypes or any 2 of the 4 serotypes or any 3 of the 4 serotypes or with all 4 serotypes were reported. |
| Number of Participants With Vaccine Viremia | 7 days post-injection 1 and 2, 14 days post-injection 1 and 2 | Vaccine viremia (level of vaccine virus in blood samples taken from participants) was measured by an assay yellow fever reverse transcriptase polymerase chain reaction which allowed the detection of vaccine viremia of any serotype (1, 2, 3 and 4). |
| Number of Participants With Solicited Injection Site Reactions After Any Vaccination | 7 days after any injection 1, 2 or 3 | Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm. Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm. |
| Number of Participants With Solicited Systemic Reactions After Any Vaccination | 14 days after any injection 1, 2 or 3 | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: - Grade1: \>=37.5°C to \<=38.0°C (\>=99.5°F to \<=100.4°F), Grade 2: \>38.0°C to \<=39.0°C (\>100.4°F to \<= 102.2°F), Grade 3: \>39.0°C (\>102.2°F). Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities. |
| Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13) | Geometric mean titers against each dengue virus serotype (1, 2, 3 and 4) strain was measured by PRNT. |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 17 April 2008 to 04 June 2008 at 5 sites in the United States.
Pre-assignment details
A total of 309 participants were screened in the study, out of which 260 participants were enrolled and vaccinated in the study. Screen failures were mainly due to inclusion criteria not met or exclusion criteria met.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine 5555 Formulation Participants received 3 doses of CYD dengue vaccine (5555 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months. | 101 |
| CYD Dengue Vaccine 5553 Formulation Participants received 3 doses of CYD dengue vaccine (5553 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months. | 101 |
| CYD Dengue Vaccine 4444 Formulation Participants received 3 doses of CYD dengue vaccine (4444 formulation); one each at 0 (vaccination 1), 6 (vaccination 2), and 12 (vaccination 3) months. | 53 |
| Total | 255 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 | 1 |
| Overall Study | Other Adverse Event | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 10 | 8 | 5 |
| Overall Study | Serious adverse event | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 8 | 9 | 2 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine 5555 Formulation | CYD Dengue Vaccine 5553 Formulation | CYD Dengue Vaccine 4444 Formulation | Total |
|---|---|---|---|---|
| Age, Continuous | 32.6 Years STANDARD_DEVIATION 8.78 | 32.1 Years STANDARD_DEVIATION 8.57 | 32.4 Years STANDARD_DEVIATION 8.04 | 32.4 Years STANDARD_DEVIATION 8.52 |
| Sex: Female, Male Female | 61 Participants | 59 Participants | 32 Participants | 152 Participants |
| Sex: Female, Male Male | 40 Participants | 42 Participants | 21 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 101 | 0 / 53 |
| other Total, other adverse events | 78 / 101 | 82 / 101 | 39 / 53 |
| serious Total, serious adverse events | 3 / 101 | 3 / 101 | 1 / 53 |
Outcome results
Primary
Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation
Percentage of participants with antibody titers \>= 10 (1/dil) against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 2 (Month 7)
Population: Analysis was performed on Full Analysis Set (FAS). Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 1: Day 0 | 1.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 1:30 days post injection-2 | 65.4 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 2: Day 0 | 1.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 2:30 days post-injection 2 | 80.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 3: Day 0 | 15.8 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 3:30 days post-injection 2 | 87.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 4: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 4:30 days post-injection 2 | 89.7 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 4:30 days post-injection 2 | 58.3 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 1: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 3: Day 0 | 14.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 1:30 days post injection-2 | 81.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 4: Day 0 | 6.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 2: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 3:30 days post-injection 2 | 92.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain: CYD Vaccine 5555 and 5553 Formulation | Dengue Virus Serotype 2:30 days post-injection 2 | 83.3 percentage of participants |
Comparison: Dengue Virus Serotype 1: Pre-injection 1 (Day 0)95% CI: [-7.44, 2.84]
Comparison: Dengue Virus Serotype 1: 30 days post-injection 295% CI: [-28.4, -2]
Comparison: Dengue Virus Serotype 2: Pre-injection 1 (Day 0)95% CI: [-7.44, 2.84]
Comparison: Dengue Virus Serotype 2: 30 days post-injection 295% CI: [-15, 8.75]
Comparison: Dengue Virus Serotype 3: Pre-injection 1 (Day 0)95% CI: [-9.09, 11.1]
Comparison: Dengue Virus Serotype 3: 30 days post-injection 295% CI: [-15.6, 3.81]
Comparison: Dengue Virus Serotype 4: Pre-injection 1 (Day 0)95% CI: [-10.9, 2.49]
Comparison: Dengue Virus Serotype 4: 30 days post-injection 295% CI: [18.2, 43.2]
Secondary
Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain
Geometric mean titers against each dengue virus serotype (1, 2, 3 and 4) strain was measured by PRNT.
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 2 | 64.5 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 3 | 63.5 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 1 | 9.97 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4: Day 0 | 5.26 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2: Day 0 | 5.13 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 2 | 150 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 3 | 133 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 1 | 438 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 1 | 16.7 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 2 | 47.5 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 2 | 24.1 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 3 | 54.8 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3: Day 0 | 6.60 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1: Day 0 | 5.04 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 1 | 45.5 Titers (1/dil) |
| CYD Dengue Vaccine 5555 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 3 | 24.4 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 2 | 45.4 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 3 | 57.1 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 1 | 39.9 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 3 | 114 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1: Day 0 | 5.57 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 2 | 117 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4: Day 0 | 5.57 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 2 | 91.9 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 1 | 12.1 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2: Day 0 | 5.53 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3: Day 0 | 6.85 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 2 | 18.3 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 1 | 20.3 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 1 | 109 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 3 | 25.9 Titers (1/dil) |
| CYD Dengue Vaccine 5553 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 3 | 102 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 3 | 134 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1: Day 0 | 5.23 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 1 | 9.29 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 2 | 19.2 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 3 | 24.2 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2: Day 0 | 5.43 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 1 | 13.1 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 2 | 31.8 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 3 | 46.5 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3: Day 0 | 6.25 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 1 | 23.3 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 2 | 40.4 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 3 | 43.1 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4: Day 0 | 5.43 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 1 | 643 Titers (1/dil) |
| CYD Dengue Vaccine 4444 Formulation | Geometric Means of Titers of Antibodies Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 2 | 164 Titers (1/dil) |
Secondary
Number of Participants With Solicited Injection Site Reactions After Any Vaccination
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 1: Easily tolerated, Grade 2: Sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm. Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>=5 cm.
Time frame: 7 days after any injection 1, 2 or 3
Population: Analysis was performed on Safety Analysis Set which included all participants included in the trial who had received at least 1 dose of study vaccine and had any available safety data. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 1 | 15 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 2 | 7 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema | 26 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 1 | 46 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 1 | 18 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain | 50 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling | 19 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 2 | 3 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 2 | 3 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 1 | 19 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain | 42 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 1 | 35 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 2 | 7 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema | 27 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 2 | 7 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling | 14 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 1 | 12 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 2 | 2 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 1 | 3 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 1 | 15 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 2 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling | 3 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain | 15 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema | 8 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 1 | 8 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Swelling: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Erythema: Grade 2 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Injection Site Reactions After Any Vaccination | Pain: Grade 2 | 0 Participants |
Secondary
Number of Participants With Solicited Systemic Reactions After Any Vaccination
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: - Grade1: \>=37.5°C to \<=38.0°C (\>=99.5°F to \<=100.4°F), Grade 2: \>38.0°C to \<=39.0°C (\>100.4°F to \<= 102.2°F), Grade 3: \>39.0°C (\>102.2°F). Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Time frame: 14 days after any injection 1, 2 or 3
Population: Analysis was performed on safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 2 | 10 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 6 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 14 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 1 | 29 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise | 39 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia | 43 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 1 | 16 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 3 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 4 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 2 | 19 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 1 | 18 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache | 58 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 2 | 8 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia | 29 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 1 | 28 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 2 | 2 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 4 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 2 | 24 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 1 | 11 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 1 | 17 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 20 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 1 | 18 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 2 | 2 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache | 59 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 1 | 38 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 2 | 18 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 3 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise | 43 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 1 | 26 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 2 | 12 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 5 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia | 49 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 1 | 30 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 2 | 17 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 2 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia | 32 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 2 | 14 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 1 | 3 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 1 | 10 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 2 | 9 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 2 | 7 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 1 | 16 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 2 | 3 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia: Grade 3 | 1 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache | 28 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever | 6 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia | 12 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 2 | 5 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 1 | 9 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Fever: Grade 2 | 3 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise: Grade 3 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Malaise | 14 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Asthenia: Grade 1 | 9 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Myalgia | 18 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Solicited Systemic Reactions After Any Vaccination | Headache: Grade 3 | 3 Participants |
Secondary
Number of Participants With Vaccine Viremia
Vaccine viremia (level of vaccine virus in blood samples taken from participants) was measured by an assay yellow fever reverse transcriptase polymerase chain reaction which allowed the detection of vaccine viremia of any serotype (1, 2, 3 and 4).
Time frame: 7 days post-injection 1 and 2, 14 days post-injection 1 and 2
Population: Analysis was performed on Viremia Analysis Set which included all participants who received study vaccination and provided at least one blood sample for which vaccine viremia laboratory results were available. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 7 days post-injection 1 | 0 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 14 days post-injection 1 | 0 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 7 days post-injection 2 | 0 Participants |
| CYD Dengue Vaccine 5555 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 14 days post-injection 2 | 0 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 14 days post-injection 2 | 0 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 7 days post-injection 1 | 0 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 7 days post-injection 2 | 0 Participants |
| CYD Dengue Vaccine 5553 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 14 days post-injection 1 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 14 days post-injection 2 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 14 days post-injection 1 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 7 days post-injection 2 | 0 Participants |
| CYD Dengue Vaccine 4444 Formulation | Number of Participants With Vaccine Viremia | Vaccine viremia 7 days post-injection 1 | 0 Participants |
Secondary
Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes
Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT. In this outcome measure, participants with antibody titers \>= 10 1/dil against any 1 of the 4 serotypes or any 2 of the 4 serotypes or any 3 of the 4 serotypes or with all 4 serotypes were reported.
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 1 | 96.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 2 | 97.6 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Day 0 | 16.8 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 1 | 80.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 2 | 90.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 3 | 90.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Day 0 | 1.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 1 | 50.5 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 2 | 72.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 3 | 82.9 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Day 0 | 0.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 1 | 16.8 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 2 | 52.4 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 3 | 62.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 1 | 74.3 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 2 | 90.5 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 3 | 95.1 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 1 | 19.8 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Day 0 | 2.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 1 | 45.5 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 3 | 59.3 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 2 | 79.8 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Day 0 | 20.8 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 2 | 47.6 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 1 | 93.1 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 3 | 86.4 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 2 | 97.6 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Day 0 | 2.0 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 2 | 63.0 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 1 | 64.2 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Day 0 | 1.9 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 2 | 97.8 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 2 | 82.6 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 3 | 53.3 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Day 0 | 17.0 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Post-injection 3 | 91.1 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 3 | 73.3 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 2 positive serotype: Day 0 | 3.8 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Day 0 | 1.9 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 1 | 11.3 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 1 | 98.1 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 3 positive serotype: Post-injection 1 | 41.5 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | At least 1 positive serotype: Post-injection 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers >=10 1/Dil Against At Least Any 1, 2, 3 or All 4 Dengue Virus Serotypes | All 4 positive serotype: Post-injection 2 | 41.3 percentage of participants |
Secondary
Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain
Percentage of participants with antibody titers \>= 10 1/dil against each serotypes (1, 2, 3 and 4) of the dengue virus strains was assessed by PRNT.
Time frame: Pre-injection 1 (Day 0), 30 days post-injection 1(Month 1), injection 2 (Month 7) and injection 3 (Month 13)
Population: Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2: Day 0 | 1.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 1 | 33.7 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 2 | 65.4 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 3 | 71.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1: Day 0 | 1.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 1 | 46.5 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 2 | 80.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 3 | 84.3 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3: Day 0 | 15.8 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 1 | 79.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 2 | 87.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 3 | 88.6 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 1 | 84.2 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 2 | 89.7 percentage of participants |
| CYD Dengue Vaccine 5555 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 3 | 94.2 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 1 | 64.4 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 2 | 83.3 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 3 | 88.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 1 | 37.6 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3: Day 0 | 14.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 1 | 80.2 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 3 | 69.1 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 2 | 92.9 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 2 | 58.3 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 1 | 50.5 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 3 | 98.8 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 2 | 81.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 3 | 84.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2: Day 0 | 3.0 percentage of participants |
| CYD Dengue Vaccine 5553 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4: Day 0 | 6.9 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 2 | 78.3 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 1 | 34.0 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4: Day 0 | 5.7 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 2 | 58.7 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 2 | 58.7 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 3 | 93.3 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1: Day 0 | 3.8 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2:30 days post-injection 3 | 77.8 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 3 | 82.2 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 2: Day 0 | 1.9 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3: Day 0 | 13.2 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 1 | 94.3 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 1 | 26.4 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 3:30 days post-injection 1 | 60.4 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 1:30 days post-injection 3 | 64.4 percentage of participants |
| CYD Dengue Vaccine 4444 Formulation | Percentage of Participants With Antibody Titers of >=10 1/Dil Against Each Dengue Virus Serotype Strain | Dengue Virus Serotype 4:30 days post-injection 2 | 89.1 percentage of participants |