Dengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue Diseases
Conditions
Keywords
Dengue virus, Dengue fever, Dengue hemorrhagic fever, Dengue diseases, Dengue vaccine
Brief summary
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the severity, due to any of the four serotypes in children aged 4 to 11 years at the time of inclusion. Secondary objectives included to assess: * Vaccine efficacy against severe VCD cases * Vaccine efficacy against VCD cases following at least two injections with CYD dengue vaccine * Immune response to CYD dengue vaccine * Safety profile of CYD dengue vaccine. Safety assessments include 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. Other objectives included: * Vaccine efficacy against VCD cases following at least one injection with CYD dengue vaccine * Vaccine efficacy against VCD cases due to each serotype * Participants with clinical signs and symptoms for VCD
Detailed description
Participants (both cohort 1 and 2) received 3 injections of CYD dengue vaccine. Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (cohort 2) received placebo at 0, 6, and 12 months. Dengue cases were collected for assessment of efficacy during the Active Phase from first injection until at least 13 months after the third injection. A subset of participants were also evaluated for reactogenicity and immunogenicity. Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue non-structural protein 1 (NS1) enzyme-linked immunosorbent assay antigen test, and occurring \>28 days after the third injection. Dengue hemorrhagic fever (DHF) Grade I, II, III, and IV according to the 1999 World Health Organization (WHO) definition: Clinical Manifestations: a) Fever: acute onset, high and continuous, lasting 2 to 7 days. b) Any of the following hemorrhagic manifestations (including at least a positive tourniquet test): petechiae, purpura, ecchymosis, epistaxis, gum bleeding, and hematemesis and/or melena. Laboratory Findings: c) thrombocytopenia (platelet count = 100 000/mm3 or less) d) Plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion (seen on chest X-ray) and/or hypoalbuminemia. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse. Independent Data Monitoring Committee (IDMC) severity criteria:- 1) Thrombocytopenia: platelet count ≤ 50 000/mm\^3 ; 2) Any hemorrhage that needs blood transfusion; 3) Objective evidence of capillary permeability documented by one or several of the following: a) Increase in hematocrit by \>= 20 percent (%) compared to normal for age, or \[(Maximum hematocrit - minimum hematocrit)/min\]\*100% \>= 20%, b) Pleural or abdominal (ascites) effusion (diagnosed either by clinical signs or radiography or other imaging method), c) Hypoproteinemia; 4) Signs of circulatory failure manifested by: a) Narrow pulse pressure \<20mm Hg, or hypotension for age (as defined by systolic pressure \<80 mm Hg in children \<5 years and systolic pressure \< 90 mm Hg in children \>= 5 years), and b) Rapid and weak pulse, and c) Signs of poor capillary perfusion (cold and clammy extremities, delayed capillary refill); 5) Visceral Manifestations such as: a) Neurological symptoms (convulsions or change in level of consciousness), b) Hepatic failure or elevation of hepatic enzyme (\>5-fold normal level), c) Metabolic (hypoglycemia) or electrolyte (hyponatremia, hypocalcemia) disturbances or volume overload (acute pulmonary edema or congestive heart failure), d) Other visceral manifestations such as cardiomyopathy, acute renal failure, acute respiratory failure, cholecystitis.
Interventions
BIOLOGICALCYD Dengue Vaccine
0.5 mL, Subcutaneous
BIOLOGICALInactivated rabies virus vaccine
0.5 mL, Subcutaneous
BIOLOGICALPlacebo
Sodium chloride 0.9%
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
The observer-blind design was chosen since the products have different appearances and could be recognized. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize the potential bias, the control group used the same route and schedule as the study vaccine.
Eligibility
Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 4 to 11 years on the day of inclusion. * Participant in good health, based on medical history and physical examination. * Provision of assent form signed by the participants (for participants \>= 7 years old) and informed consent form signed by the parent or another legally acceptable representative. * Participant and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures. * Participant attended one of the schools involved in the trial and living in the Ratchaburi Province. * For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
Exclusion criteria
: * Febrile illness (temperature \>= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment. * For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination. * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. * 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, 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. * Receipt of blood or blood-derived products in the past 3 months. * Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. * Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.e * Participant who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5 degree Celsius (°C) measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue non-structural protein-1 (NS1) enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | GMT of antibodies against each serotype with the parental dengue virus strain were assessed by the plaque reduction neutralization test (PRNT). |
| GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue immune participants were defined as those participants with titers \>= 10 (1/dilution) against at least one dengue serotype at baseline. |
| GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3 | GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue non-immune participants were defined as participants with titers \< 10 (1/dilution) against all four dengue serotypes at baseline. |
| Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 7 days post-any Inj. and each of the 3 Inj. | 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: \> 0.0 to \< 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 Either CYD Dengue Vaccine or a Placebo | 14 days post-any Inj. and each of the 3 Inj. | Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5°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. |
| Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months) | The severity of VCD cases was assessed by WHO 1999 severity assessment and IDMC clinical assessment. Dengue Hemorrhagic Fever (DHF) Grade I, II, III, and IV : Clinical Manifestations: a) Fever: acute onset, high and continuous, lasting 2-7 days, b) Any of hemorrhagic manifestations: petechiae, purpura, ecchymosis, epistaxis, gum bleeding, and hematemesis and/or melena, c) thrombocytopenia (platelet count=100 000/mm3 or less) d) Plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion and/or hypoalbuminemia. IDMC severity criteria: 1) Thrombocytopenia: platelet count \<= 50 000/mm\^3; 2) Hemorrhage that needs blood transfusion; 3) Objective evidence of capillary permeability 4) Signs of circulatory failure; 5) Visceral Manifestations. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
| Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Inj. 2 up to Inj. 3, 28 days Post-Inj. 2 up to end of Active Phase ( up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by dengue reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months) | Clinical signs and symptoms for VCD included the following: fever, clinical syndrome and hospitalization. Duration of each symptom (in days) is reported in this outcome measure. |
| Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months) | — |
| Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Day 0 (Post-Inj.) up to end of Active phase (up to 25 months); 28 days post-Inj. 1 up to end of Active phase (up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>=37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk. |
| Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | After 28 days Post Inj. 3 up to the end of Active Phase (up to 25 months) | Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. VCD cases confirmed only by NS1 method were classified in the Not Identified category. Cases were defined as the number of participants with at least one symptomatic VCD episode more than 28 days after Inj. 3 (during the Active Phase). |
Countries
Thailand
Participant flow
Recruitment details
Study participants were enrolled from 05 February 2009 to 05 February 2010 at 1 clinical site in Thailand. A total of 4002 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; however, only 3997 participants received the first vaccination.
Pre-assignment details
Two-step enrollment approach was followed. Cohort 1 (100 participants \[CYD vaccine arm\] received CYD vaccine as Injection \[Inj.\] 1 and 50 \[control group arm\] received rabies vaccine as Inj. 1) was enrolled first. After 14 days review of Cohort 1 safety data in both arms, cohort 2 was enrolled (2569 participants in CYD group; 1283 in control group).
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Participants (both Cohort 1 and 2) received 3 injections of the CYD Dengue vaccine, 1 Inj. each at 0, 6 months, and 12 months. | 2,666 |
| Control Group Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (Cohort 2) received placebo at 0, 6, and 12 months. | 1,331 |
| Total | 3,997 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 |
| Overall Study | Other adverse event | 6 | 1 |
| Overall Study | Protocol Violation | 32 | 14 |
| Overall Study | Serious adverse event | 0 | 6 |
| Overall Study | Withdrawal by Subject | 73 | 28 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 8.16 years STANDARD_DEVIATION 2.03 | 8.20 years STANDARD_DEVIATION 2.05 | 8.17 years STANDARD_DEVIATION 2.03 |
| Sex: Female, Male Female | 1376 Participants | 696 Participants | 2072 Participants |
| Sex: Female, Male Male | 1290 Participants | 635 Participants | 1925 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 2,666 | 4 / 1,331 |
| other Total, other adverse events | 415 / 697 | 207 / 350 |
| serious Total, serious adverse events | 315 / 2,666 | 176 / 1,331 |
Outcome results
Primary
Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo
Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5 degree Celsius (°C) measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue non-structural protein-1 (NS1) enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.
Time frame: 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months)
Population: Analysis was performed on Per-protocol analysis (PPA) set for efficacy which included participants with no protocol deviations. Participants with following protocol deviations were excluded: inclusion criteria not met or exclusion criteria met, randomization error, Inj. not performed, code breaking and delay between the inj. not respected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYD Dengue Vaccine Group | Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 45 Cases |
| Control Group | Number of Symptomatic Virologically-Confirmed Dengue (VCD) Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | 32 Cases |
Comparison: Vaccine efficacy of CYD dengue vaccine: The statistical methodology was based on the use of the two-sided 95% confidence interval (CI) of the vaccine efficacy. The CI was calculated using the exact method conditional on the total number of cases in both groups.95% CI: [-13.4, 56.6]
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo
GMT of antibodies against each serotype with the parental dengue virus strain were assessed by the plaque reduction neutralization test (PRNT).
Time frame: Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3
Population: Analysis was performed on Full Analysis Set for Immunogenicity defined as the participants included in the subgroup for Immunogenicity assessment who have received at least one dose and who had a blood sample drawn after vaccination. 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 With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 1 | 31.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 3 | 116 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 1 | 112 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 1 | 195 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 2 | 81.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 1 | 94.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 2 | 218 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 2 | 152 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 3 | 240 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 3 | 155 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 3 | 351 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 2 | 351 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; 1 year Post-Inj. 3 | 125 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 2 | 184 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 1 | 28.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 3 | 239 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 1 | 138 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; 1 year Post-Inj. 3 | 120 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 2 | 74.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 3 | 358 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 2 | 183 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 2 | 78.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 3 | 110 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; 1 year Post-Inj. 3 | 158 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 3 | 151 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 1 | 56.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; 1 year Post-Inj. 3 | 152 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 1 | 42.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; 1 year Post-Inj. 3 | 45.9 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 1 | 26.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 1 | 27.7 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 2 | 30.5 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 2 | 28.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 3 | 26.4 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 3 | 27.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; 1 year Post-Inj. 3 | 35.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 1 | 43.7 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 1 | 42.9 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 2 | 50.5 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 2 | 44.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 3 | 54.8 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 3 | 52.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; 1 year Post-Inj. 3 | 46.1 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 1 | 28.7 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 1 | 27.0 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 2 | 31.1 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 2 | 26.9 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 3 | 50.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 3 | 46.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; 1 year Post-Inj. 3 | 35.1 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 1 | 23.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 1 | 24.2 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 2 | 25.6 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 2 | 25.3 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 3 | 24.4 Titers (1/dilution) |
| Control Group | Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 3 | 22.1 Titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo
GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue immune participants were defined as those participants with titers \>= 10 (1/dilution) against at least one dengue serotype at baseline.
Time frame: Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3
Population: Analysis was performed on Full Analysis Set for Immunogenicity. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 1 | 69.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 3 | 254 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 1 | 216 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 1 | 449 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 2 | 152 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 1 | 235 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 2 | 308 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 2 | 340 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 3 | 361 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 3 | 283 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 3 | 469 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 2 | 619 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; 1 year Post-Inj. 3 | 213 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 2 | 371 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 1 | 58.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 3 | 413 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 1 | 212 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; 1 year Post-Inj. 3 | 262 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 2 | 121 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 3 | 562 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 2 | 266 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 2 | 193 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 3 | 170 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; 1 year Post-Inj. 3 | 332 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 3 | 198 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 1 | 161 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; 1 year Post-Inj. 3 | 234 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 1 | 107 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; 1 year Post-Inj. 3 | 89.6 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 1 | 57.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 1 | 59.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 2 | 68.4 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 2 | 58.9 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 3 | 49.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 3 | 50.6 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; 1 year Post-Inj. 3 | 67.0 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 1 | 119 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 1 | 112 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 2 | 139 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 2 | 117 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 3 | 132 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 3 | 118 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; 1 year Post-Inj. 3 | 99.1 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 1 | 63.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 1 | 56.1 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 2 | 66.1 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 2 | 52.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 3 | 107 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 3 | 91.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; 1 year Post-Inj. 3 | 61.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 1 | 46.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 1 | 49.7 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 2 | 53.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 2 | 51.8 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 3 | 45.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 3 | 40.1 Titers (1/dilution) |
Secondary
GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo
GMTs of antibodies against each serotype with the parental dengue virus strain were assessed by the PRNT. Dengue non-immune participants were defined as participants with titers \< 10 (1/dilution) against all four dengue serotypes at baseline.
Time frame: Pre-Inj. 1, 2, and 3, 28 days Post-Inj. 1, 2 and 3 and 1 year Post-Inj. 3
Population: Analysis was performed on Full Analysis Set for Immunogenicity. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 3 | 17.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 1 | 23.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 1 | 27.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 2 | 17.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 1 | 11.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 2 | 93.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 2 | 21.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 3 | 89.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 3 | 35.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 3 | 174 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 2 | 88.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; 1 year Post-Inj. 3 | 33.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 2 | 33.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 3 | 63.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 1 | 50.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; 1 year Post-Inj. 3 | 17.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 2 | 22.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 3 | 120 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 2 | 73.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 2 | 8.72 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 3 | 38.8 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; 1 year Post-Inj. 3 | 25.2 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 3 | 78.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; 1 year Post-Inj. 3 | 52.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; 1 year Post-Inj. 3 | 10.3 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 1 | 5.24 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 2 | 5.31 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 2 | 5.62 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Pre-Inj. 3 | 6.86 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; Post-Inj. 3 | 7.47 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1; 1 year Post-Inj. 3 | 8.76 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 1 | 5.19 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 2 | 5.41 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 2 | 5.38 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Pre-Inj. 3 | 8.12 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; Post-Inj. 3 | 8.64 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2; 1 year Post-Inj. 3 | 8.31 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 1 | 5.43 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 2 | 6.05 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 2 | 6.23 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Pre-Inj. 3 | 9.78 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; Post-Inj. 3 | 10.2 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3; 1 year Post-Inj. 3 | 9.89 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 1 | 5.00 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 1 | 5.00 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 2 | 5.26 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 2 | 5.20 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Pre-Inj. 3 | 6.41 Titers (1/dilution) |
| Control Group | GMTs of Antibodies Against Each Serotype With the Parental Dengue Virus Strain in Dengue Non-Immune Participants Before and Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4; Post-Inj. 3 | 5.98 Titers (1/dilution) |
Secondary
Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo
The severity of VCD cases was assessed by WHO 1999 severity assessment and IDMC clinical assessment. Dengue Hemorrhagic Fever (DHF) Grade I, II, III, and IV : Clinical Manifestations: a) Fever: acute onset, high and continuous, lasting 2-7 days, b) Any of hemorrhagic manifestations: petechiae, purpura, ecchymosis, epistaxis, gum bleeding, and hematemesis and/or melena, c) thrombocytopenia (platelet count=100 000/mm3 or less) d) Plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion and/or hypoalbuminemia. IDMC severity criteria: 1) Thrombocytopenia: platelet count \<= 50 000/mm\^3; 2) Hemorrhage that needs blood transfusion; 3) Objective evidence of capillary permeability 4) Signs of circulatory failure; 5) Visceral Manifestations. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.
Time frame: 28 days Post-Inj. 3 up to the end of Active Phase (up to 13 months Post-Inj. 3, i.e. up to 25 months)
Population: Analysis was performed on PPA set for efficacy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Severe VCD cases (IDMC clinical assessment) | 1 Cases |
| CYD Dengue Vaccine Group | Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Severe VCD cases (WHO 1999 severity assessment) | 2 Cases |
| Control Group | Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Severe VCD cases (IDMC clinical assessment) | 2 Cases |
| Control Group | Number of Severe VCD Cases During the Active Phase Post-dose 3 Following Inj. With Either CYD Dengue Vaccine or a Placebo | Severe VCD cases (WHO 1999 severity assessment) | 2 Cases |
Comparison: Vaccine efficacy against severe VCD (IDMC)95% CI: [-377, 99.6]
Comparison: Vaccine efficacy of against severe VCD (WHO 1999)95% CI: [-585, 96.4]
Secondary
Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo
Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by dengue reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.
Time frame: 28 days Post-Inj. 2 up to Inj. 3, 28 days Post-Inj. 2 up to end of Active Phase ( up to 25 months)
Population: Analysis was performed on Other Efficacy Analysis Set 2 which included all participants who received at least the two first injections.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | Cases: 28 days Post-Inj. 2 up to Inj. 3 | 14 Cases |
| CYD Dengue Vaccine Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | Cases:28 days Post-Inj. 2 upto end of Active Phase | 61 Cases |
| Control Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | Cases: 28 days Post-Inj. 2 up to Inj. 3 | 12 Cases |
| Control Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least Two Inj. With Either CYD Dengue Vaccine or a Placebo | Cases:28 days Post-Inj. 2 upto end of Active Phase | 47 Cases |
Comparison: Vaccine efficacy:- 28 days Post-Inj. 2 up to Inj. 395% CI: [-38.4, 74.9]
Comparison: Vaccine efficacy: 28 days Post-Inj. 2 up to end of Active Phase95% CI: [3.3, 56.5]
Secondary
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo
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: \> 0.0 to \< 2.5 cm, Grade 2: \>= 2.5 to \< 5 cm, Grade 3: \>= 5 cm.
Time frame: 7 days post-any Inj. and each of the 3 Inj.
Population: Analysis was performed in the Reactogenicity Analysis Set, which included all participants who received at least one injection and were considered evaluable for reactogenicity. 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 1 | 33.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Any Inj. | 0.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Any Inj. | 28.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Any Inj. | 21.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Any Inj. | 57.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 1 | 13.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 1 | 9.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 1 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 2 | 35.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 | 0.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 2 | 13.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 2 | 11.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 3 | 33.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 3 | 13.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | 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 Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 3 | 10.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 3 | 10.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Any Inj. | 57.6 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 2 | 32.2 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Any Inj. | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 3 | 30.5 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Any Inj. | 30.7 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Any Inj. | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Any Inj. | 22.1 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 2 | 14.6 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Any Inj. | 0.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Pain; Post-Inj. 1 | 30.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Pain; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 3 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 1 | 16.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 2 | 11.1 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Erythema; Post-Inj. 1 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema; Post-Inj. 3 | 14.5 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling; Post-Inj. 1 | 9.2 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 2 | 0.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj. site Swelling; Post-Inj. 1 | 0.3 Percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5°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-any Inj. and each of the 3 Inj.
Population: Analysis was performed on Reactogenicity 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 Either CYD Dengue Vaccine or a Placebo | Fever: Post-Inj. 2 | 14.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Inj. 1 | 13.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Inj. 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Any Inj. | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Inj. 2 | 31.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Any Inj. | 1.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Inj. 2 | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Inj. 1 | 39.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Inj. 2 | 27.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Any Inj. | 50.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Inj. 2 | 0.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Inj. 1 | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Inj. 2 | 28.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Any Inj. | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Inj. 2 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Inj. 1 | 32.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Inj. 2 | 21.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Any Inj. | 1.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Inj. 2 | 0.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Inj. 1 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Inj. 3 | 11.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Any Inj. | 32.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Inj. 3 | 0.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Inj. 1 | 30.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Inj. 3 | 27.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Any Inj. | 43.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Inj. 3 | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Inj. 1 | 0.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Inj. 3 | 25.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Any Inj. | 53.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Inj. 3 | 0.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Inj. 1 | 25.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Inj. 3 | 26.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Any Inj. | 1.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Inj. 3 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Inj. 1 | 0.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Inj. 3 | 19.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Any Inj. | 60.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Inj. 3 | 0.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Inj. 1 | 1.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Inj. 3 | 1.2 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Any Inj. | 34.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Any Inj. | 4.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Any Inj. | 59.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Any Inj. | 2.6 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Any Inj. | 50.7 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Any Inj. | 2.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Any Inj. | 47.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Any Inj. | 2.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Any Inj. | 41.8 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Any Inj. | 2.6 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Inj. 1 | 14.7 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Inj. 1 | 1.8 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Inj. 1 | 35.2 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Inj. 1 | 1.7 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Inj. 1 | 29.5 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Inj. 1 | 1.1 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Inj. 1 | 24.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Inj. 1 | 2.0 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Inj. 1 | 23.5 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Inj. 1 | 1.1 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Inj. 2 | 16.7 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Inj. 2 | 1.2 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Inj. 2 | 29.8 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Inj. 2 | 0.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Inj. 2 | 24.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Inj. 2 | 0.6 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Inj. 2 | 25.1 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Inj. 2 | 0.6 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Inj. 2 | 21.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia: Post-Inj. 2 | 0.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Fever: Post-Inj. 3 | 12.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever: Post-Inj. 3 | 1.5 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Headache: Post-Inj. 3 | 32.5 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache: Post-Inj. 3 | 0.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Malaise: Post-Inj. 3 | 24.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise: Post-Inj. 3 | 0.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Myalgia: Post-Inj. 3 | 24.9 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia: Post-Inj. 3 | 0.3 Percentage of participants |
| Control Group | Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo | Asthenia: Post-Inj. 3 | 23.4 Percentage of participants |
Other Pre-specified
Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo
Clinical signs and symptoms for VCD included the following: fever, clinical syndrome and hospitalization. Duration of each symptom (in days) is reported in this outcome measure.
Time frame: Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months)
Population: Analysis was performed on Safety Analysis Set. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CYD Dengue Vaccine Group | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Fever | 4.13 Days | Standard Deviation 1.98 |
| CYD Dengue Vaccine Group | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Clinical syndrome | 5.39 Days | Standard Deviation 2.34 |
| CYD Dengue Vaccine Group | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Hospitalization | 4.91 Days | Standard Deviation 1.33 |
| Control Group | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Fever | 4.40 Days | Standard Deviation 1.97 |
| Control Group | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Clinical syndrome | 5.84 Days | Standard Deviation 2.68 |
| Control Group | Mean Number of Days for Clinical Signs and Symptoms (Fever, Clinical Syndrome and Hospitalization) of VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Hospitalization | 5.17 Days | Standard Deviation 1.97 |
Other Pre-specified
Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo
Time frame: Day 0 (Post-Inj.) up to end of Active Phase (up to 25 months)
Population: Analysis was performed on Safety Analysis Set. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Hospitalization; No | 44 participants |
| CYD Dengue Vaccine Group | Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Hospitalization; Yes | 32 participants |
| Control Group | Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Hospitalization; No | 32 participants |
| Control Group | Number of Participants Requiring Hospitalization for VCD During the Active Phase Following Inj. With Either CYD Dengue Vaccine or a Placebo | Hospitalization; Yes | 30 participants |
Other Pre-specified
Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo
Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>= 37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. VCD cases confirmed only by NS1 method were classified in the Not Identified category. Cases were defined as the number of participants with at least one symptomatic VCD episode more than 28 days after Inj. 3 (during the Active Phase).
Time frame: After 28 days Post Inj. 3 up to the end of Active Phase (up to 25 months)
Population: Analysis was performed on Other Efficacy Analysis Set 1.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2 | 52 Participants |
| CYD Dengue Vaccine Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4 | 1 Participants |
| CYD Dengue Vaccine Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3 | 4 Participants |
| CYD Dengue Vaccine Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Not Identified | 5 Participants |
| CYD Dengue Vaccine Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1 | 14 Participants |
| Control Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Not Identified | 1 Participants |
| Control Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 1 | 18 Participants |
| Control Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 2 | 27 Participants |
| Control Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 3 | 11 Participants |
| Control Group | Number of Participants With One VCD Episode During the Active Phase Due to Each Serotypes Following Inj. With Either CYD Dengue Vaccine or a Placebo | Dengue Virus Serotype 4 | 5 Participants |
Other Pre-specified
Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo
Symptomatic VCD cases were defined as acute febrile illness with fever lasting for at least 1 day (temperature \>=37.5°C measured at least twice with an interval of at least 4 hours), confirmed by reverse transcriptase-polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay antigen test, and occurring more than 28 days after the third injection. Vaccine efficacy was reported as density incidence (cases/100 person-years at risk). Density incidence was defined as the number of VCD cases divided by the cumulative person-years at risk.
Time frame: Day 0 (Post-Inj.) up to end of Active phase (up to 25 months); 28 days post-Inj. 1 up to end of Active phase (up to 25 months)
Population: Analysis was performed on Other Efficacy Analysis Set 1 which included participants who received at least the first injection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Cases:28 days Post-Inj.1 upto end of Active Phase | 75 Cases |
| CYD Dengue Vaccine Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Cases:Day 0 upto end of Active Phase | 76 Cases |
| Control Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Cases:28 days Post-Inj.1 upto end of Active Phase | 56 Cases |
| Control Group | Number of Symptomatic VCD Cases During the Active Phase Following at Least One Inj. With Either CYD Dengue Vaccine or a Placebo | Cases:Day 0 upto end of Active Phase | 58 Cases |
Comparison: Vaccine efficacy: 28 days Post-Inj. 1 up to end of Active Phase95% CI: [4.1, 53.5]
Comparison: Vaccine efficacy: Day 0 up to end of Active Phase95% CI: [6.7, 54.3]