Dengue, Dengue Hemorrhagic Fever, Yellow Fever
Conditions
Keywords
Dengue, Dengue Hemorrhagic Fever, CYD Dengue Vaccines, Yellow Fever, Stamaril®, Flavivirus Infections
Brief summary
The study was designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration. Primary Objective: * To demonstrate the non-inferiority of the immune response against Yellow Fever (YF) in flavivirus (FV) non-immune subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to participants receiving one dose of Stamaril vaccine concomitantly with placebo. Secondary Objectives: * To assess the non-inferiority of YF immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of participants at baseline. * To describe the YF immune response 28 days post-Stamaril vaccination in both groups. * To describe the antibody (Ab) response to each dengue virus serotype 28 days post CYD dengue vaccine (Visit \[V\] 05 and V07), following CYD dengue vaccine Dose 1 and Dose 2 from Group 2 versus following CYD dengue vaccine Dose 2 and Dose 3 for Group 1 (effect of YF vaccination). * To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo. * To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone. * To describe the safety of the CYD dengue vaccine in all participants after each dose.
Detailed description
All participants received a total of 9 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies was performed in a randomized subset of participants. All participants were followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.
Interventions
BIOLOGICALLive, attenuated dengue serotype 1, 2, 3, and 4 virus
0.5 mL, subcutaneous at age 12, 18, and 24 months
BIOLOGICALYellow fever vaccine
0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
BIOLOGICALMeasles, mumps, and rubella (MMR) vaccine
0.5 mL, subcutaneous at age 12 to 13 months.
BIOLOGICALPneumococcal Conjugated Vaccine
0.5 mL, intramuscular at age 13 to 14 months
BIOLOGICALHepatitis A Pediatric Vaccine
0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
BIOLOGICALDiphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine
0.5 mL, intramuscular at age 19 to 20 months
BIOLOGICALYellow Fever Vaccine
0.5 mL, subcutaneous at age 12 to 13 months
BIOLOGICALPlacebo (NaCl)
0.5 mL, subcutaneous at age 12 to 13 months
BIOLOGICALMeasles, mumps, and rubella vaccine
0.5 mL, subcutaneous at age 13 to 14 months
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
To ensure that objective safety data were obtained, the trial was designed using an observer-blind methodology since the products were visually different and may be recognized. For first trial vaccination (V01), the person who administered the injections knew which products were administered while either the participant or parent nor the Investigator in charge of safety evaluation knew which products were administered.
Eligibility
Sex/Gender
ALL
Age
12 Months to 13 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 12 to 13 months on the day of inclusion. * Born at full term of pregnancy (\>=37 weeks) and with a birth weight \>=2.5 kg as reported by the parent/legally acceptable representative. * Participant in good health, based on medical history and physical examination. * Participant had completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively. * Informed consent form had been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations). * Participant and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination. * Planned participation in another clinical trial during the present trial period. * Planned receipt of any vaccine in the 4 weeks following first trial vaccination. * Previous vaccination against YF, hepatitis A, or measles, mumps and rubella. * Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative. * History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative. * Personal history of YF or dengue infection/disease as reported by the parent/legally acceptable representative. * Known systemic hypersensitivity to any of the vaccine components of the vaccines that were used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances. * History of contraindication to receipt of vaccines containing components of Stamaril® (yellow fever vaccine), measles, mumps and rubella vaccine, hepatitis A vaccine, pneumococcal conjugated vaccine or of diphtheria (D) toxoid, tetanus (T) toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio or other diphtheria, tetanus and pertussis vaccine (e.g., DTwP). * Thrombocytopenia, as reported by the parent/legally acceptable representative. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular (IM) vaccination. * History of central nervous system disorder or disease, including seizures. * Personal history of thymic pathology (e.g., thymoma), and/or thymectomy. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Identified as a child (adopted or natural) of the Investigator or of employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Injection 1 | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28-days Post-Injection 1 | GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. |
| Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28- days Post-Injection 1 | GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. |
| Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28-days Post-Injection 1 | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dil) regardless of the flavivirus status of participants at baseline. |
| GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28-days Post-Injections 2 and 3 | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay. |
| GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28-days Post-Injections 2 and 3 | GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. |
| Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28-days Post-Injections 2 and 3 | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers \>= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains. |
| Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 28 days Post-Injection 1 | Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline. |
| GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28 days Post-Injections 2 and 3 | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with \>= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus. |
| GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28 days Post-Injections 2 and 3 | GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with \<10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus. |
| Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28 days Post-Injections 2 and 3 | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with \>= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus. |
| Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28 days Post-Injections 2 and 3 | Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with \<10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus. |
| Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3 | Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>39.5°celsius; Vomiting: \>= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine. |
| Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 and 28 days Post-Injections 2 and 3 | Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. |
Countries
Colombia, Peru
Participant flow
Recruitment details
Study participants were enrolled from 07 September 2011 to 08 March 2012 at 2 clinical sites (1 in Colombia and 1 in Peru).
Pre-assignment details
A total of 792 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized; 787 participants were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Participants received the Stamaril® and the CYD dengue vaccine (Injection 1) at enrolment (M0) at age 12 to 13 months; measles, mumps and rubella vaccine, pneumococcal conjugated vaccine, hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenza type b (DTaP IPV/Hib) vaccine at M7 (age 19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). | 394 |
| Placebo Group Participants received the Stamaril® vaccine and placebo matched to CYD vaccine (Injection 1) at enrolment (M0) (age 12 to 13 months); measles, mumps, and rubella vaccine, pneumococcal conjugate vaccine and hepatitis A vaccine at M1 (age 13 to 14 months); CYD dengue vaccine (Injection 2) at M6 (age 18 to 19 months); DTaP IPV/Hib vaccine at M7 (age19 to 20 months); and CYD dengue vaccine (Injection 3) at M12 (age 24 to 25 months); and hepatitis A vaccine at M13 (age 25 to 26 months). | 393 |
| Total | 787 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lost to Follow-up | 3 | 3 |
| Overall Study | Protocol Violation | 7 | 5 |
| Overall Study | Serious adverse event | 2 | 3 |
| Overall Study | Withdrawal by Subject | 19 | 29 |
Baseline characteristics
| Characteristic | CYD Dengue Vaccine Group | Placebo Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 394 Participants | 393 Participants | 787 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.2 Months STANDARD_DEVIATION 0.25 | 12.2 Months STANDARD_DEVIATION 0.25 | 12.2 Months STANDARD_DEVIATION 0.25 |
| Sex: Female, Male Female | 198 Participants | 203 Participants | 401 Participants |
| Sex: Female, Male Male | 196 Participants | 190 Participants | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 394 | 1 / 393 |
| other Total, other adverse events | 211 / 394 | 193 / 393 |
| serious Total, serious adverse events | 35 / 394 | 38 / 393 |
Outcome results
Primary
Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dilution \[dil\]) in flavivirus non-immune participants (defined as those with YF antibodies \<10 \[1/dil\] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).
Time frame: 28 days Post-Injection 1
Population: Analysis was performed on Per-Protocol analysis set which included all participants who had no protocol deviations. Per-Protocol analysis set was defined for the Stamaril® vaccine immune response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 100.0 Percentage of participants |
| Placebo Group | Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 99.7 Percentage of participants |
Comparison: Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).95% CI: [-0.976, 1.87]
Secondary
Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Time frame: Pre-Injection 1 and 28- days Post-Injection 1
Population: Analysis was performed on Full analysis set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 35.1 Ratio |
| Placebo Group | Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 39.8 Ratio |
Secondary
Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.
Time frame: Pre-Injection 1 and 28-days Post-Injection 1
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 | 5.64 Titers (1/dilution) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Post-Injection 1 | 369 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 | 5.67 Titers (1/dilution) |
| Placebo Group | Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Post-Injection 1 | 423 Titers (1/dilution) |
Secondary
GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj.2/Pre-Inj. 1 | 4.78 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj.2/Pre-Inj. 1 | 9.55 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj.3/Pre-Inj. 1 | 18.0 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj.3/Pre-Inj. 1 | 8.82 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj.2/Pre-Inj. 1 | 6.82 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj.3/Pre-Inj. 1 | 16.7 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj.3/Pre-Inj. 1 | 7.26 Titer ratios |
| CYD Dengue Vaccine Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj.2/Pre-Inj. 1 | 11.6 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj.3/Pre-Inj. 1 | 7.44 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj.2/Pre-Inj. 1 | 1.15 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj.3/Pre-Inj. 1 | 6.14 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj.2/Pre-Inj. 1 | 3.86 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj.3/Pre-Inj. 1 | 15.2 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj.2/Pre-Inj. 1 | 4.16 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj.3/Pre-Inj. 1 | 15.4 Titer ratios |
| Placebo Group | GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj.2/Pre-Inj. 1 | 2.89 Titer ratios |
Secondary
GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay.
Time frame: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Population: Analysis performed on Full analysis set for dengue immunogenicity which included participants who received at least 1dose of CYD dengue vaccine/placebo, had at least 1 blood sample withdrawn and valid post vaccination test results for at least 1 dengue serotype. Here,'number analyzed' =participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.08 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 47.3 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 89.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.10 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 95.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 173 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.05 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 118 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 181 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 68.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 74.0 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 29.8 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.18 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 11.8 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.05 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 61.3 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 43.4 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 74.6 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 41.1 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 155 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 150 Titers (1/dilution) |
Secondary
GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with \>= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus.
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants 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 Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 52.5 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.74 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 6.14 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 102 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.96 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 72.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 81.7 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 87.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 110 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 77.1 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 143 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 74.3 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 17.0 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 59.5 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 74.3 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 133 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 6.75 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 95.8 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 126 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.41 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 109 Titers (1/dilution) |
Secondary
GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with \<10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants 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 Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 45.9 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 86.6 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 99.0 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 174 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 118 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 184 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 66.4 Titers (1/dilution) |
| CYD Dengue Vaccine Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 73.0 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 24.0 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 11.4 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 61.8 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 37.9 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 5.00 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 72.2 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 39.0 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 160 Titers (1/dilution) |
| Placebo Group | GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 157 Titers (1/dilution) |
Secondary
Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline.
Time frame: 28 days Post-Injection 1
Population: Analysis performed on Full analysis set included participants who received at least co-administration of Stamaril® vaccine with either 1st dose of CYD dengue vaccine or placebo, had blood sample post-Stamaril® vaccination drawn and a valid test result. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CYD Dengue Vaccine Group | Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 98.7 Percentage of participants |
| Placebo Group | Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | 99.7 Percentage of participants |
Comparison: Non-inferiority of YF seroconversion rate was assessed 28 days post-Stamaril®/CYD dengue vaccine (CYD Dengue Vaccine Group) or post-Stamaril®/placebo (Placebo Group).95% CI: [-2.81, 0.383]
Secondary
Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies \>=10 (1/dil) regardless of the flavivirus status of participants at baseline.
Time frame: Pre-Injection 1 and 28-days Post-Injection 1
Population: Analysis was performed on Full analysis set. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 | 9.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Post-Injection 1 | 99.5 Percentage of participants |
| Placebo Group | Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Pre-Injection 1 | 9.0 Percentage of participants |
| Placebo Group | Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Post-Injection 1 | 99.7 Percentage of participants |
Secondary
Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with \>= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus.
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 10.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 90.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 20.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 12.5 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 100.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 100.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 0.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 90.0 percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 88.9 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 92.9 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 0.0 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 30.8 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 57.1 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 7.7 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 100.0 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 100.0 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 0.0 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 100.0 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 92.9 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 100.0 percentage of participants |
| Placebo Group | Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 100.0 percentage of participants |
Secondary
Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with \<10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Population: Analysis was performed on Full analysis set for dengue immunogenicity. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 92.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 96.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 97.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 90.4 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 97.7 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 51.1 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 96.5 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 86.7 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 100.0 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 87.8 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 100.0 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 63.3 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: \>=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: \>39.5°celsius; Vomiting: \>= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses \>=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine.
Time frame: Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3
Population: Analysis was performed on Safety analysis set. Here, 'number analyzed' = participants with available data for each specified category. 0 in number analyzed field= none of the participants were evaluable since participants did not received CYD dengue vaccine as Injection 1 (Placebo group) or Placebo at any time point (CYD dengue vaccine group).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue; Post-Inj. 3 | 3.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj site Tenderness, CYDdengue;Post-Any Inj | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Injection 3 | 19.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Inj. 3 | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for Stamaril®; Post-Inj. 1 | 25.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Injection 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Any Injection | 48.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, Stamaril®; Post-Inj. 1 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Any Injection | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Injection 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Any Injection | 30.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue; Post-Inj. 1 | 24.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Any Injection | 1.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Any Injection | 47.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for Stamaril®; Post-Any Inj. | 8.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Any Injection | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Injection 3 | 14.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Any Injection | 36.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for Stamaril®; Post-Inj. 1 | 8.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Any Injection | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, Stamaril®;Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Any Injection | 54.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj.site Erythema for Stamaril®; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Any Injection | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Injection 3 | 7.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Any Injection | 46.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue; Post-Inj. 1 | 8.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Any Injection | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 1 | 26.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue;Post-Any Inj. | 12.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 1 | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Injection 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Injection 1 | 16.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for Stamaril®; Post-Inj. 1 | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Injection 1 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue;Post-Any Inj | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Injection 1 | 32.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj.site Swelling for Stamaril®; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Injection 1 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Injection 3 | 11.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Injection 1 | 24.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Inj. 1 | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Injection 1 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Injection 1 | 39.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for Stamaril®; Post-Any Inj. | 25.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Injection 1 | 4.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Injection 3 | 15.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Injection 1 | 38.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue; Post-Inj. 2 | 17.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Injection 1 | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for Stamaril®; Post-Any Inj. | 4.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 2 | 21.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, Stamaril®;Post-Any Inj | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Injection 2 | 12.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue; Post-Inj. 2 | 5.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Injection 2 | 0.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, Stamaril®; Post-Any Inj. | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Injection 2 | 19.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Injection 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Injection 3 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Injection 2 | 12.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Inj. 2 | 2.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Injection 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Any Inj. | 7.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Injection 2 | 27.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Injection 2 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue;Post-Any Inj. | 36.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Injection 2 | 17.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue; Post-Inj. 3 | 14.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Injection 2 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Any Inj | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 3 | 20.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 3 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 3 | 0.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Injection 3 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Injection 2 | 23.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Injection 2 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Injection 2 | 22.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 3 | 17.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Injection 3 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 3 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Injection 3 | 7.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Injection 3 | 0.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Injection 3 | 14.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Injection 3 | 10.7 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Injection 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Injection 3 | 18.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Injection 3 | 16.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Injection 3 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for Stamaril®; Post-Any Inj. | 17.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, Stamaril®;Post-Any Inj | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue;Post-Any Inj. | 28.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj site Tenderness, CYDdengue;Post-Any Inj | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for placebo; Post-Any Inj. | 19.7 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, placebo;Post-Any Inj. | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for Stamaril®; Post-Any Inj. | 9.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, Stamaril®;Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue;Post-Any Inj. | 8.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue;Post-Any Inj | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for placebo; Post-Any Inj. | 10.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema for placebo; Post-Any Inj | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for Stamaril®; Post-Any Inj. | 4.4 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, Stamaril®; Post-Any Inj. | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Any Inj. | 6.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Any Inj | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for placebo; Post-Any inj. | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling for placebo; Post-Any Inj | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for Stamaril®; Post-Inj. 1 | 17.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, Stamaril®; Post-Inj. 1 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for placebo; Post-Inj. 1 | 19.7 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, placebo; Post-Inj. 1 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for Stamaril®; Post-Inj. 1 | 9.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj.site Erythema for Stamaril®; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for placebo; Post-Inj. 1 | 10.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema for placebo; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for Stamaril®; Post-Inj. 1 | 4.4 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj.site Swelling for Stamaril®; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for placebo; Post-Inj. 1 | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling for placebo; Post-Inj. 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue; Post-Inj. 2 | 20.4 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue; Post-Inj. 2 | 8.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Inj. 2 | 4.7 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Tenderness for CYD dengue; Post-Inj. 3 | 16.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Tenderness, CYD dengue; Post-Inj 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Erythema for CYD dengue; Post-Inj. 3 | 4.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Erythema, CYD dengue; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Inj. site Swelling for CYD dengue; Post-Inj. 3 | 2.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grd 3 Inj. site Swelling, CYD dengue; Post-Inj. 3 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Any Injection | 40.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Any Injection | 0.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Any Injection | 27.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Any Injection | 2.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Any Injection | 44.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Any Injection | 1.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Any Injection | 33.9 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Any Injection | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Any Injection | 50.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Any Injection | 3.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Any Injection | 46.4 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Any Injection | 1.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 1 | 16.5 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 1 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Injection 1 | 17.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Injection 1 | 1.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Injection 1 | 32.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Injection 1 | 1.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Injection 1 | 22.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Appetite lost; Post-Injection 1 | 33.7 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Appetite lost; Post-Injection 1 | 3.1 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Irritability; Post-Injection 1 | 34.7 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Irritability; Post-Injection 1 | 1.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 2 | 22.2 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 2 | 0.3 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Vomiting; Post-Injection 2 | 8.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Vomiting; Post-Injection 2 | 0.6 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Crying abnormal; Post-Injection 2 | 21.8 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Crying abnormal; Post-Injection 2 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Drowsiness; Post-Injection 2 | 16.5 Percentage of participants |
| Placebo Group | Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Grade 3 Drowsiness; Post-Injection 2 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.
Time frame: Pre-Injection 1 and 28 days Post-Injections 2 and 3
Population: Analysis was performed Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 | 3.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 | 94.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 | 85.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 | 97.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 | 41.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 | 4.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 | 93.8 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 | 100.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 | 73.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 | 97.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 | 87.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 | 98.1 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo
Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers \>= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains.
Time frame: Pre-Injection 1 and 28-days Post-Injections 2 and 3
Population: Analysis was performed Full analysis set for dengue immunogenicity. Here, 'number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 92.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 1.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 97.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 91.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 97.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 | 68.1 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 | 3.7 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 | 51.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 | 0.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 | 97.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 | 90.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 | 98.1 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 | 86.7 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 | 100.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 | 100.0 Percentage of participants |