Dengue, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue, Dengue hemorrhagic fever, CYD Dengue Vaccines
Brief summary
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: * To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine. * To evaluate the safety of each vaccination with CYD dengue vaccine.
Detailed description
Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.
Interventions
BIOLOGICALLive, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
0.5 mL, Subcutaneous (SC)
BIOLOGICALNaCl 0.9%
0.5 mL, Subcutaneous
BIOLOGICALTetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
0.5 mL, Intramuscular
BIOLOGICALMeningococcal A+C vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 9 to 16 years on the day of inclusion * Participant in good health, based on medical history and physical examination * Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative * Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures * For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination
Exclusion criteria
: * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia * For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1 * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * Breast-feeding woman * Planned participation in another clinical trial during the present trial period * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator * Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures * Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination * Planned receipt of any vaccine in the 4 weeks following the first trial vaccination * Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent * Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination * Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Day 0 up to Day 14 post each vaccination | Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity. |
| Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer. |
| Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 Days after each injection | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer. |
| Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer. |
| Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer. |
| Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). |
| Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer. |
| Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Before and 28 days after each injection | Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer. |
Countries
Brazil
Participant flow
Recruitment details
Study participants were enrolled from 20 August 2010 to 8 December 2011 at 1 clinical site in Brazil.
Pre-assignment details
A total of 150 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months. | 100 |
| Control Group Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months. | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 2 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Control Group | CYD Dengue Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 100 Participants | 150 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 Age Continuous | 12.7 Years STANDARD_DEVIATION 2.2 | 12.7 Years STANDARD_DEVIATION 2.1 | 12.7 Years STANDARD_DEVIATION 2.15 |
| Region of Enrollment Brazil | 50 Participants | 100 Participants | 150 Participants |
| Sex: Female, Male Female | 23 Participants | 59 Participants | 82 Participants |
| Sex: Female, Male Male | 27 Participants | 41 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 61 / 100 | 25 / 50 |
| serious Total, serious adverse events | 5 / 100 | 3 / 50 |
Outcome results
Primary
Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time frame: Before and 28 days after each injection
Population: Geometric mean titer ratios were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) | 4.15 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 7.26 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 1.66 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 4.92 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 1.07 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post -nj. 3 / Pre-Inj. 3 (n=89, 46) | 1.48 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) | 4.67 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 6.80 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 1.97 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 6.21 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 1.78 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 3 (n=89, 46) | 1.40 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) | 6.50 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 8.57 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 2.03 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 6.26 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 1.46 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46) | 1.53 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48) | 17.7 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 15.4 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 1.84 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 20.2 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 2.26 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post -nj. 3 / Pre-Inj. 3 (n=87, 46) | 1.68 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 0.912 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) | 0.834 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) | 0.916 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 2.11 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=99, 48) | 0.806 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 1.25 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 1.85 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 1.36 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 1.4 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 0.793 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 1.02 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post -nj. 3 / Pre-Inj. 3 (n=89, 46) | 0.706 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 1.27 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=99, 49) | 0.733 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 1.24 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=94, 47) | 1.75 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post -nj. 3 / Pre-Inj. 3 (n=87, 46) | 0.723 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 0.981 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 0.673 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=89, 46) | 1.68 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=94, 47) | 0.835 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=89, 46) | 0.944 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=88, 46) | 0.8 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 3 (n=89, 46) | 0.851 Titer ratio |
Primary
Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Time frame: Before and 28 days after each injection
Population: Geometric mean titer ratios were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 1.02 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 5.73 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 3.25 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 5.34 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 3.03 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 3 (n=16, 8) | 2.19 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 1.03 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 8.62 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 6.02 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 7.67 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 5.36 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post -nj. 3 / Pre-Inj. 3 (n=16, 8) | 2.37 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 5.41 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 21.2 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 7.58 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 16.3 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 5.83 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8) | 3.35 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 16.5 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 22.7 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 3.15 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 25.5 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 3.53 Titer ratio |
| CYD Dengue Vaccine Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8) | 2.55 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 0.701 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 0.861 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 0.701 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 0.861 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Inj. 3 / Pre-Inj. 3 (n=16, 8) | 0.446 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 1 / Pre-Inj. 1 (n=19, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 0.678 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 1 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8) | 0.578 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 0.678 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 1 (n=16, 8) | 0.737 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Inj. 2 / Pre-Inj. 2 (n=16, 8) | 0.5 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Inj. 3 / Pre-Inj. 2 (n=16, 8) | 0.737 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Inj. 3 / Pre-Inj. 3 (n=15, 8) | 0.524 Titer ratio |
| Control Group | Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post -nj. 3 / Pre-Inj. 3 (n=16, 8) | 0.538 Titer ratio |
Primary
Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time frame: Before and 28 days after each injection
Population: Geometric mean titers were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=99, 49) | 67.0 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=99, 49) | 41.4 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=99, 49) | 256 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=94, 47) | 230 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=90, 46) | 162 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=89, 46) | 267 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=94, 47) | 436 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=99, 49) | 352 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=94, 47) | 287 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=94, 47) | 647 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=90, 46) | 360 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=89, 46) | 544 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=99, 49) | 81.9 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=99, 49) | 690 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=94, 47) | 471 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=94, 47) | 1031 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=89, 46) | 481 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=89, 46) | 741 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=99, 49) | 15.0 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=99, 48) | 383 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=94, 47) | 178 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=94, 47) | 346 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=88, 46) | 258 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=89, 46) | 432 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=88, 46) | 37.4 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=94, 47) | 130 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=99, 49) | 94.7 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=99, 49) | 47.2 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=99, 49) | 17.5 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=99, 49) | 50.7 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=99, 49) | 110 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=94, 47) | 86 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=94, 47) | 31.2 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=90, 46) | 90.8 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=94, 47) | 184 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=89, 46) | 79.2 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=99, 48) | 19.2 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=99, 49) | 68.3 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=94, 47) | 227 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=99, 49) | 62.8 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=89, 46) | 33.4 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=94, 47) | 117 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=89, 46) | 144 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=94, 47) | 137 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=94, 47) | 27.8 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=90, 46) | 131 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=89, 46) | 140 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=89, 46) | 132 Titers (1/dilutions) |
Primary
Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Time frame: Before and 28 days after each injection
Population: Geometric mean titers were assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=80, 41) | 124 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=80, 41) | 549 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=78, 39) | 430 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=78, 39) | 661 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=74, 38) | 268 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=73, 38) | 381 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=80, 41) | 68.5 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=80, 41) | 816 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=78, 39) | 591 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=78, 39) | 978 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=74, 38) | 648 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=73, 38) | 835 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=80, 41) | 159 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=80, 41) | 1263 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=78, 39) | 879 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=78, 39) | 1426 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=74, 38) | 776 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=73, 38) | 1031 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=80, 41) | 19.5 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=80, 40) | 467 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=78, 39) | 220 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=78, 39) | 377 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=73, 38) | 313 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=73, 38) | 485 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=73, 38) | 53.9 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=80, 41) | 73.1 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=80, 41) | 168 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=80, 41) | 79.8 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=80, 41) | 22.4 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=78, 39) | 154 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=80, 41) | 202 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=78, 39) | 253 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=78, 39) | 45.3 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=74, 38) | 143 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=78, 39) | 387 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=73, 38) | 126 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=80, 40) | 25.2 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=80, 41) | 114 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=78, 39) | 497 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=80, 41) | 103 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=73, 38) | 46.5 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=78, 39) | 224 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=74, 38) | 272 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=78, 39) | 271 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=78, 39) | 39.5 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=74, 38) | 240 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=73, 38) | 266 Titers (1/dilutions) |
| Control Group | Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=73, 38) | 242 Titers (1/dilutions) |
Primary
Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Time frame: Before and 28 days after each injection
Population: Seropositivity was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=80, 41) | 81.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=80, 41) | 88.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=78, 39) | 91.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=74, 38) | 87.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=73, 38) | 98.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=80, 41) | 73.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=80, 41) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=78, 39) | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=74, 38) | 91.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=73, 38) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=80, 41) | 77.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=80, 41) | 95.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=78, 39) | 93.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=74, 38) | 97.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=73, 38) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=80, 41) | 58.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=80, 40) | 95.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=78, 39) | 94.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=73, 38) | 98.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=73, 38) | 100.0 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=73, 38) | 81.6 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=80, 41) | 75.6 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=80, 41) | 78 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=80, 41) | 82.9 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=80, 41) | 61 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=80, 41) | 80.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=78, 39) | 71.8 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=74, 38) | 81.6 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=73, 38) | 81.6 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=80, 40) | 70 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=80, 41) | 80.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=80, 41) | 80.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=73, 38) | 84.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=78, 39) | 89.7 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=74, 38) | 84.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=78, 39) | 69.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=74, 38) | 89.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=73, 38) | 86.8 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=73, 38) | 89.5 Percentage of participants |
Primary
Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.
Time frame: Before and 28 days after each injection
Population: Seropositivity was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 (n=80, 41) | 77.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 1 (n=80, 41) | 97.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 2 (n=78, 39) | 97.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 3 (n=74, 38) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 (n=73, 38) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 (n=80, 41) | 85.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 1 (n=80, 41) | 95.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 2 (n=78, 39) | 97.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 3 (n=74, 38) | 95.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 (n=73, 38) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 (n=80, 41) | 70.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 1 (n=80, 41) | 92.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 2 (n=78, 39) | 91.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 3 (n=74, 38) | 93.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 (n=73, 38) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 (n=80, 41) | 58.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 1 (n=80, 41) | 87.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 2 (n=78, 39) | 85.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 (n=78, 39) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 3 (n=74, 38) | 85.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 (n=73, 38) | 98.6 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 3 (n=74, 38) | 73.7 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 (n=80, 41) | 85.4 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 (n=80, 41) | 73.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 1 (n=80, 41) | 85.4 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 (n=80, 41) | 56.1 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 2 (n=78, 39) | 89.7 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 1 (n=80, 41) | 78 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 (n=78, 39) | 89.7 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 (n=78, 39) | 71.8 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 3 (n=74, 38) | 92.1 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 (n=73, 38) | 89.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 1 (n=80, 41) | 63.4 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 (n=80, 41) | 80.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 (n=78, 39) | 84.6 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 1 (n=80, 41) | 85.4 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 (n=73, 38) | 78.9 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 2 (n=78, 39) | 89.7 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 3 (n=74, 38) | 84.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 (n=78, 39) | 87.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 2 (n=78, 39) | 66.7 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 3 (n=74, 38) | 86.8 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 (n=73, 38) | 84.2 Percentage of participants |
| Control Group | Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 (n=73, 38) | 89.5 Percentage of participants |
Primary
Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Time frame: Before and 28 days after each injection
Population: Seropositivity was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 1 (n=19, 8) | 94.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 2 (n=16, 8) | 81.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 3 (n=16, 8) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 1 (n=19, 8) | 78.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 2 (n=16, 8) | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 3 (n=16, 8) | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 1 (n=19, 8) | 36.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 2 (n=16, 8) | 37.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 (n=16, 8) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 3 (n=16, 8) | 56.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 (n=16, 8) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 1 (n=19, 8) | 10.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 2 (n=16, 8) | 18.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 (n=16, 8) | 75.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 3 (n=16, 8) | 37.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 (n=16, 8) | 87.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 (n=16, 8) | 25 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
Primary
Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with \<10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.
Time frame: Before and 28 Days after each injection
Population: Seropositivity was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=19, 8) | 42.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=16, 8) | 31.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=16, 8) | 75.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=16, 8) | 37.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=16, 8) | 87.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=19, 8) | 26.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=16, 8) | 25.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=16, 8) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=16, 8) | 56.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=16, 8) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=19, 8) | 84.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=16, 8) | 68.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=15, 8) | 80.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=19, 8) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=19, 8) | 68.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=16, 8) | 81.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=16, 8) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=15, 8) | 93.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=16, 8) | 100.0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=15, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=19, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=16, 8) | 25 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=15, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=16, 8) | 0 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
| Control Group | Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=16, 8) | 12.5 Percentage of participants |
Primary
Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo
Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, \>10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.
Time frame: Day 0 up to Day 14 post each vaccination
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Inj. 2 (N=93,47) | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-Any Inj. (N=100,49) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Any Inj. (N=100,49) | 4.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Any Inj. (N=100,49) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Any Inj. (N=100,49) | 5.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Any Inj. (N=100,49) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Injection 1 (N=99,49) | 26.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Pain; Post-Inj. 1 (N=99,49) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Inj. 1 (N=99,49) | 1.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Inj. 1 (N=99,49) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Inj. 1 (N=99,49) | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Inj. 1 (N=99,49) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Injection 2 (N=93,47) | 21.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Pain; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Inj. 2 (N=93,47) | 3.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Any Injection (N=100,49) | 40 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Injection 3 (N=89,45) | 16.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Pain; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Inj. 3 (N=89,45) | 1.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Any Injection (N=100, 49) | 30.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Any Injection (N=100, 49) | 8.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Any Injection (N=100, 49) | 61.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Any Injection (N=100, 49) | 15.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Any Injection (N=100, 49) | 40.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Any Injection (N=100, 49) | 11.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Any Injection (N=100, 49) | 42.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Any Injection (N=100, 49) | 6.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Any Injection (N=100, 49) | 35.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Any Injection (N=100, 49) | 8.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 1 (N=98, 48) | 15.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 1 (N=98, 48) | 3.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Injection 1 (N=99, 49) | 48.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Injection 1 (N=99, 49) | 8.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Injection 1 (N=99, 49) | 31.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Injection 1 (N=99, 49) | 3.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Injection 1 (N=99, 49) | 32.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Injection 1 (N=99, 49) | 2.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Injection 1 (N=99, 49) | 22.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Injection 1 (N=99, 49) | 4.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 2 (N=92, 47) | 8.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 2 (N=92, 47) | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Injection 2 (N=94, 47) | 28.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Injection 2 (N=94, 47) | 5.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Injection 2 (N=94, 47) | 18.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Injection 2 (N=94, 47) | 6.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Injection 2 (N=94, 47) | 20.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Injection 2 (N=94, 47) | 3.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Injection 2 (N=94, 47) | 12.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Injection 2 (N=94, 47) | 3.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 3 (N=82, 43) | 11.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 3 (N=82, 43) | 3.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Injection 3 (N=89, 45) | 27.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Injection 3 (N=89, 45) | 5.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Injection 3 (N=89, 45) | 15.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Injection 3 (N=89, 45) | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Injection 3 (N=89, 45) | 20.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Injection 3 (N=89, 45) | 2.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Injection 3 (N=89, 45) | 14.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Injection 3 (N=89, 45) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Injection 3 (N=89, 45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Any Injection (N=100,49) | 40.8 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Any Injection (N=100, 49) | 20.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-Any Inj. (N=100,49) | 4.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Injection 2 (N=94, 47) | 17 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Any Inj. (N=100,49) | 2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Any Injection (N=100, 49) | 4.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Any Inj. (N=100,49) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Injection 3 (N=89, 45) | 20 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Any Inj. (N=100,49) | 4.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 1 (N=98, 48) | 10.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Any Inj. (N=100,49) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Injection 2 (N=94, 47) | 4.3 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Injection 1 (N=99,49) | 30.6 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 1 (N=98, 48) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Pain; Post-Inj. 1 (N=99,49) | 2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Injection 3 (N=89, 45) | 11.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Inj. 1 (N=99,49) | 2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Injection 1 (N=99, 49) | 40.8 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Inj. 1 (N=99,49) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Injection 2 (N=94, 47) | 21.3 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Inj. 1 (N=99,49) | 4.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Injection 1 (N=99, 49) | 10.2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Inj. 1 (N=99,49) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Injection 3 (N=89, 45) | 8.9 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Injection 2 (N=93,47) | 14.9 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Injection 1 (N=99, 49) | 18.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Pain; Post-Inj. 2 (N=93,47) | 2.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Injection 2 (N=94, 47) | 4.3 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Injection 1 (N=99, 49) | 2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Injection 3 (N=89, 45) | 4.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Injection 1 (N=99, 49) | 30.6 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Inj. 2 (N=93,47) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Injection 2 (N=94, 47) | 14.9 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Injection-site Pain; Post-Injection 3 (N=89,45) | 15.6 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Injection 1 (N=99, 49) | 6.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Pain; Post-Inj. 3 (N=89,45) | 2.2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Injection 3 (N=89, 45) | 11.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Erythema; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Asthenia; Post-Injection 1 (N=99, 49) | 10.2 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Erythema; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Injection 2 (N=94, 47) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Inj.-site Swelling; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Asthenia; Post-Injection 1 (N=99, 49) | 4.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Gr 3 Inj.-site Swelling; Post-Inj. 3 (N=89,45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Injection 3 (N=89, 45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Any Injection (N=100, 49) | 18.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 2 (N=92, 47) | 4.3 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Any Injection (N=100, 49) | 6.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Fever; Post-Injection 3 (N=82, 43) | 7 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Any Injection (N=100, 49) | 51 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 2 (N=92, 47) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Any Injection (N=100, 49) | 20.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Injection 3 (N=89, 45) | 0 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Malaise; Post-Any Injection (N=100, 49) | 32.7 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Headache; Post-Injection 2 (N=94, 47) | 34 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Malaise; Post-Any Injection (N=100, 49) | 6.1 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Fever; Post-Injection 3 (N=82, 43) | 7 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Myalgia; Post-Any Injection (N=100, 49) | 42.9 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Headache; Post-Injection 2 (N=94, 47) | 6.4 Percentage of participants |
| Control Group | Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo | Grade 3 Myalgia; Post-Any Injection (N=100, 49) | 8.2 Percentage of participants |
Primary
Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time frame: Before and 28 days after each injection
Population: Seropositivity was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=99, 49) | 65.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=99, 49) | 79.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=94, 47) | 80.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post Injection 2 (n=94, 47) | 95.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=90, 46) | 78.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=89, 46) | 96.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=99, 49) | 59.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=99, 49) | 80.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=94, 47) | 80.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=94, 47) | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=90, 46) | 85.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=89, 46) | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=99, 49) | 62.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=99, 49) | 92.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=94, 47) | 89.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=94, 47) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=89, 46) | 94.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=89, 46) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=99, 49) | 47.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post -njection 1 (n=99, 48) | 89.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=94, 47) | 92.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=94, 47) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=88, 46) | 97.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=89, 46) | 100.0 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 3 (n=88, 46) | 69.6 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 1 (n=99, 49) | 63.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 1 (n=99, 49) | 65.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 1 (n=99, 49) | 69.4 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 1 (n=99, 49) | 51 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 1 (n=99, 49) | 67.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 2 (n=94, 47) | 59.6 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Pre-Injection 3 (n=90, 46) | 69.6 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 1; Post-Injection 3 (n=89, 46) | 69.6 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post -njection 1 (n=99, 48) | 58.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 1 (n=99, 49) | 67.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 1 (n=99, 49) | 67.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Post-Injection 3 (n=89, 46) | 73.9 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 2 (n=94, 47) | 74.5 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Pre-Injection 3 (n=89, 46) | 71.7 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 4; Pre-Injection 2 (n=94, 47) | 57.4 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Pre-Injection 3 (n=90, 46) | 76.1 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 3; Post-Injection 3 (n=89, 46) | 73.9 Percentage of participants |
| Control Group | Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | Serotype 2; Post-Injection 3 (n=89, 46) | 76.1 Percentage of participants |
Primary
Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo
Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
Time frame: Before and 28 days after each injection
Population: Seropositivity was assessed in the Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 1 (n=99, 49) | 97.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 (n=99, 49) | 56.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 (n=99, 49) | 62.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 1 (n=99, 49) | 81.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 (n=94, 47) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 2 (n=94, 47) | 81.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 3 (n=90, 46) | 76.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 (n=94, 47) | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 1 (n=99, 49) | 91.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 3 (n=90, 46) | 86.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 (n=99, 49) | 68.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 (n=89, 46) | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 2 (n=94, 47) | 92.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 (n=99, 49) | 47.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 3 (n=90, 46) | 98.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 1 (n=99, 49) | 72.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 (n=94, 47) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 2 (n=94, 47) | 74.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 2 (n=94, 47) | 94.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 (n=94, 47) | 95.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 3 (n=90, 46) | 91.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 (n=89, 46) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 (n=89, 46) | 96.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 (n=89, 46) | 100.0 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 1 (n=99, 49) | 71.4 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 1 (n=99, 49) | 71.4 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 2 (n=94, 47) | 74.5 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 2 (n=94, 47) | 74.5 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Pre-Injection 3 (n=90, 46) | 78.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 1 serotype; Post-Injection 3 (n=89, 46) | 78.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 1 (n=99, 49) | 67.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 1 (n=99, 49) | 71.4 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 2 (n=94, 47) | 74.5 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 2 (n=94, 47) | 72.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-Injection 3 (n=90, 46) | 73.9 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 2 serotypes; Post-Injection 3 (n=89, 46) | 76.1 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 1 (n=99, 49) | 61.2 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 1 (n=99, 49) | 65.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 2 (n=94, 47) | 70.2 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-Injection 3 (n=90, 46) | 71.7 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | At least 3 serotypes; Post-Injection 3 (n=89, 46) | 71.7 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 1 (n=99, 49) | 46.9 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 1 (n=99, 49) | 53.1 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 2 (n=94, 47) | 55.3 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 2 (n=94, 47) | 59.6 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Pre-Injection 3 (n=90, 46) | 63 Percentage of participants |
| Control Group | Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo | All 4 serotypes; Post-Injection 3 (n=89, 46) | 67.4 Percentage of participants |