Dengue Disease, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus
Conditions
Keywords
Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases, Dengue vaccine
Brief summary
This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: * To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children. * To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts. * To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.
Detailed description
Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.
Interventions
BIOLOGICALCYD dengue vaccine serotypes (1, 2, 3, 4).
0.5 mL, Subcutaneous
BIOLOGICALMeningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Each at 0.5 mL, Subcutaneous, respectively
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The first and second vaccinations were administered in a blind-observer manner. The third vaccination was planned to be administered in a single-blind manner; however, due to the cancellation of the statistical analysis after the second vaccination, the third vaccination was also administered in a blind- observer manner. To ensure the blind-observer design of the 3 vaccinations, the product was prepared in a separate room whether neither the Investigator nor participant had access.
Eligibility
Sex/Gender
ALL
Age
2 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 2 to 45 years on the day of inclusion. * Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years). * Participant (and parent/guardian for participants \<18 years) able to attend all scheduled visits and to comply with all trial procedures. * For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination. * Participant in good health, based on medical history, physical examination and laboratory parameters.
Exclusion criteria
: * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening. * For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection. * Breast-feeding female participant. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening. * Planned participation in another clinical trial during the first year of the study. * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy. * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines 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 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. * Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening. * 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 receipt of any vaccine in the 4 weeks following the first trial vaccination. * Familial atopy medical history (parents, brothers, or sisters). * Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion. * History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3 | Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT). |
| Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Year 1, Year 2, Year 3 and Year 4 after the Third Injection | GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT. |
| Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3 | Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT. |
| Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Year 1, Year 2, Year 3 and Year 4 after the Third Injection | Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT. |
| Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | 7 days post-each injection | Solicited Inj. 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 and Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>= 5 cm. |
| Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | 14 days post-each injection | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5 degree Celsius (°C) to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. 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. |
Countries
Vietnam
Participant flow
Recruitment details
Study participants were enrolled from 18 March 2009 to 01 July 2010 at 1 clinical center in Vietnam.
Pre-assignment details
A total of 180 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection. | 120 |
| Control Group Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection. | 60 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 0 |
| Overall Study | Serious adverse event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 10.9 Years STANDARD_DEVIATION 8.6 | 11.8 Years STANDARD_DEVIATION 9.6 | 11.2 Years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 62 Participants | 25 Participants | 87 Participants |
| Sex: Female, Male Male | 58 Participants | 35 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 60 |
| other Total, other adverse events | 42 / 120 | 48 / 60 |
| serious Total, serious adverse events | 3 / 120 | 3 / 60 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Population: Analysis was performed on Per-protocol analysis (PPA) set which included participants who received at least 1 dose of the study vaccine and had no protocol deviations, randomization error, blood sample not taken within the period and forbidden treatments. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 1 | 33.1 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 1 | 70.9 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 2 | 52.2 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 2 | 100 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 3 | 70.9 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 3 | 129 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 1 | 32.7 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 1 | 92.3 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 2 | 74.8 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 2 | 195 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 3 | 111 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 3 | 216 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 1 | 31.9 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 1 | 95.6 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 2 | 60.4 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 2 | 152 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 3 | 87.2 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 3 | 169 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 1 | 17.0 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 1 | 104 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 2 | 51.7 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 2 | 120 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 3 | 70.1 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 3 | 146 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 3 | 17.1 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 1 | 19.6 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 1 | 20.5 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 1 | 18.8 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 1 | 13.9 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 2 | 19.8 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 1 | 18.4 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 2 | 20.6 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 2 | 14.3 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 3 | 24.6 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 2 | 19.1 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 3 | 25.3 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 1 | 15.4 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 1 | 27.2 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 2 | 21.9 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 1 | 25.0 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 3 | 17.4 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 2 | 29.5 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 3 | 26.8 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 2 | 29.3 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 2 | 14.1 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 3 | 32.3 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 3 | 25.2 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 3 | 30.4 Titers (1/dil) |
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Time frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Population: Analysis was performed on Full analysis set which included all the participants present at first vaccination (V01) and received at least one dose of vaccine. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 4 | 30.2 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 1 | 103 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 2 | 72.9 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 3 | 56.0 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 4 | 52.6 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 1 | 133 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 2 | 118 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 3 | 78.1 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 4 | 73.7 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 1 | 145 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 2 | 88.2 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 3 | 66.6 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 4 | 42.7 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 1 | 87.5 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 2 | 56.9 Titers (1/dil) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 3 | 47.3 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 3 | 21.7 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 4 | 18.2 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 4 | 50.7 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 1 | 28.4 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 4 | 19.7 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 2 | 25.7 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 1 | 31.8 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 3 | 29.7 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 2 | 17.5 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 1: Year 4 | 30.5 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 2 | 26.1 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 1 | 36.9 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 4: Year 1 | 19.0 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 2 | 42.6 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 3: Year 3 | 24.4 Titers (1/dil) |
| Control Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period | Dengue Parental Serotype 2: Year 3 | 45.2 Titers (1/dil) |
Primary
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Time frame: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Population: Analysis was performed on PPA set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 1 | 49.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 1 | 62.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 2 | 58.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 2 | 79.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 3 | 68.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 3 | 93.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 1 | 50.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 1 | 66.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 2 | 63.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 2 | 93.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 3 | 80.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 3 | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 1 | 63.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 1 | 84.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 2 | 73.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 2 | 94.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 3 | 85.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 3 | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 1 | 44.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 1 | 77.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 2 | 73.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 2 | 89.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 3 | 84.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 3 | 95.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 2 | 40.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 1 | 43.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 1 | 52.5 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 1 | 41.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 1 | 37.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 2 | 39.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 1 | 47.5 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 2 | 41.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 3 | 43.1 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Pre-Inj. 3 | 46.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 2 | 46.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 1; Post-Inj. 3 | 41.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 3 | 43.1 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 1 | 41.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 2 | 53.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 1 | 35.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Pre-Inj. 2 | 39.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 2 | 39.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Pre-Inj. 3 | 62.1 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 2 | 41.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 4; Post-Inj. 1 | 41.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Pre-Inj. 3 | 43.1 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 3; Post-Inj. 3 | 58.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine | Dengue Parental Serotype 2; Post-Inj. 3 | 43.1 Percentage of participants |
Primary
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Time frame: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 1 | 78.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 2 | 74.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 3 | 59.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 4 | 61.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 1 | 86.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 2 | 82.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 3 | 70.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 4 | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 1 | 92.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 2 | 86.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 3 | 75.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 4 | 70.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 1 | 88.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 2 | 90.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 3 | 87.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 4 | 76.8 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 4 | 42.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 1 | 43.9 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 1 | 54.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 2 | 38.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 1 | 47.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 3 | 40.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 2 | 54.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 1: Year 4 | 40.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 3 | 47.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 1 | 47.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 3 | 54.5 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 2 | 49.1 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 4: Year 2 | 40.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 3 | 50.9 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 3: Year 4 | 44.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period | Dengue Parental Serotype 2: Year 4 | 53.7 Percentage of participants |
Primary
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Solicited Inj. 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 and Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>= 5 cm.
Time frame: 7 days post-each injection
Population: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Inj. 1 | 15.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Any Inj. | 6.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Any Inj. | 4.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Any Inj. | 28.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Inj. 1 | 4.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Inj. 1 | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Inj. 2 | 15.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Inj. 2 | 4.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Inj. 2 | 2.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Inj. 3 | 11.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Inj. 3 | 2.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Inj. 3 | 6.9 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Any Inj. | 80 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Inj. 2 | 15.5 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Any Inj. | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Inj. 3 | 41.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Any Inj. | 21.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Any Inj. | 1.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Any Inj. | 15.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Inj. 2 | 5.2 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Any Inj. | 1.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Pain; Post-Inj. 1 | 73.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Pain; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Inj. 1 | 16.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Inj. 2 | 3.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Erythema; Post-Inj. 1 | 1.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Erythema; Post-Inj. 3 | 5.2 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Inj. site Swelling; Post-Inj. 1 | 6.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Inj. site Swelling; Post-Inj. 1 | 1.7 Percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5 degree Celsius (°C) to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. 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 post-each injection
Population: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Inj. 1 | 19.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Any Inj. | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Any Inj. | 35.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Any Inj. | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Any Inj. | 29.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Any Inj. | 20.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Any Inj. | 13.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Any Inj. | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Any Inj. | 27.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Inj. 1 | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Inj. 1 | 29.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Inj. 1 | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Inj. 1 | 21.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Inj. 1 | 15.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Inj. 1 | 8.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Inj. 1 | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Inj. 2 | 12.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Inj. 2 | 15.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Inj. 2 | 13.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Inj. 2 | 9.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Inj. 2 | 6.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Inj. 2 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Inj. 3 | 3.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Inj. 3 | 8.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Inj. 3 | 5.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Inj. 3 | 4.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Inj. 3 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Any Inj. | 26.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Inj. 2 | 6.9 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Any Inj. | 3.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Inj. 3 | 8.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Any Inj. | 30.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Any Inj. | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Any Inj. | 23.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Inj. 2 | 8.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Any Inj. | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Any Inj. | 23.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Any Inj. | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Any Inj. | 5.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Inj. 2 | 8.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Any Inj. | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Inj. 3 | 10.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Fever; Post-Inj. 1 | 15.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Fever; Post-Inj. 1 | 3.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Inj. 3 | 10.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Headache; Post-Inj. 1 | 28.3 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Inj. 2 | 5.2 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Headache; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Inj. 1 | 16.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Malaise; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Inj. 3 | 3.4 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Myalgia; Post-Inj. 1 | 20.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Inj. 2 | 1.7 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Myalgia; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Malaise; Post-Inj. 3 | 8.6 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Asthenia; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine | Grade 3 Asthenia; Post-Inj. 1 | 0.0 Percentage of participants |