Dengue, Dengue Fever, Dengue Hemorrhagic Fever
Conditions
Keywords
Dengue Fever, Dengue Hemorrhagic Fever, CYD Dengue Vaccine, Dengue Virus, Flavivirus
Brief summary
The aim of this study is to evaluate the immunogenicity and safety of the CYD dengue vaccine in India adult subjects. Primary Objectives: * To describe the neutralizing antibody response to each dengue virus serotype before the first vaccination and after each vaccination with CYD dengue vaccine in all subjects. * To describe the safety of the CYD dengue vaccine after each dose in all subjects. Secondary Objective: * To detect symptomatic dengue cases occurring at any time in the trial.
Detailed description
Participants will receive 3 doses of their randomized treatment (vaccine or placebo). Flavivirus status will be determined at baseline (before the first dose) and the vaccine immunogenicity assessment will be at 28 days after each vaccination. Reactogenicity data will be collected in all subjects after each dose. Serious adverse events and adverse events of special interest will be collected throughout the study.
Interventions
BIOLOGICALLive, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
BIOLOGICALPlacebo: NaCl 0.9% solution
0.5 ml, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 45 years on the day of inclusion * Informed consent form has been signed and dated by the subject (and by an independent witness, if applicable) * Subject is able to attend all scheduled visits and to comply with all trial procedures * Subject in good health, based on medical history and physical examination
Exclusion criteria
* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) * Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Planned receipt of any vaccine in the 4 weeks following any trial vaccination * Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * Known seropositivity for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C reported by the subject * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as an Investigator or employee of the Investigator or study center, with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). |
| Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). |
| Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). |
| Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). |
| Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Day 0 up to Day 14 post each injection | Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling \>100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. |
| Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. |
| Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. |
| Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. |
| Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. |
| Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. |
| Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus. |
| Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1) | Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus. |
Countries
India
Participant flow
Recruitment details
Study participants were enrolled from 27 March 2012 to 28 June 2012 at 5 clinical centers in India.
Pre-assignment details
A total of 189 participants who met all inclusion and no exclusion criteria were randomized and vaccinated in this trial; 187 were included in the Full Analysis Set.
Participants by arm
| Arm | Count |
|---|---|
| CYD Dengue Vaccine Group Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine. | 126 |
| Placebo Group Healthy adult participants received 3 vaccinations of placebo vaccine. | 61 |
| Total | 187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 3 |
Baseline characteristics
| Characteristic | Placebo Group | CYD Dengue Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 126 Participants | 187 Participants |
| Age, Continuous | 29.6 Years STANDARD_DEVIATION 6.41 | 29.5 Years STANDARD_DEVIATION 7.17 | 29.5 Years STANDARD_DEVIATION 6.91 |
| Region of Enrollment India | 61 Participants | 126 Participants | 187 Participants |
| Sex: Female, Male Female | 9 Participants | 27 Participants | 36 Participants |
| Sex: Female, Male Male | 52 Participants | 99 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 127 | 3 / 61 |
| serious Total, serious adverse events | 1 / 127 | 1 / 61 |
Outcome results
Primary
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Pre-injection 1 (N=126, 61) | 86.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 1 (N=126, 61) | 99.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 2 (N=117, 58) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 3 (N=115, 57) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-injection 1 (N=126, 61) | 84.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 1 (N=126, 61) | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 2 (N=117, 58) | 98.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 3 (N=115, 57) | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-injection 1 (N=126, 61) | 82.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 1 (N=126, 61) | 92.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 2 (N=117, 58) | 98.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 3 (N=115, 57) | 97.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Pre-injection 1 (N=126, 61) | 75.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 1 (N=126, 61) | 89.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 2 (N=117, 58) | 94.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 3 (N=115, 57) | 97.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 3 (N=115, 57) | 84.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Pre-injection 1 (N=126, 61) | 88.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-injection 1 (N=126, 61) | 83.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 1 (N=126, 61) | 90.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Pre-injection 1 (N=126, 61) | 77.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 2 (N=117, 58) | 86.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 1 (N=126, 61) | 88.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 3 (N=115, 57) | 91.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 2 (N=117, 58) | 77.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-injection 1 (N=126, 61) | 85.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 2 (N=117, 58) | 81.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 1 (N=126, 61) | 88.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 1 (N=126, 61) | 80.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 2 (N=117, 58) | 82.8 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 3 (N=115, 57) | 87.7 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 3 (N=115, 57) | 89.5 Percentage of participants |
Primary
Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=126, 61) | 83.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=125, 61) | 91.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=117, 58) | 94.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=115, 57) | 97.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=126, 61) | 83.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=126, 61) | 94.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=117, 58) | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=115, 57) | 97.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=126, 61) | 84.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=126, 61) | 98.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=117, 58) | 98.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=115, 57) | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=126, 61) | 77.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=126, 61) | 96.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=117, 57) | 99.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=115, 57) | 100.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=115, 57) | 84.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=126, 61) | 80.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=126, 61) | 86.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=125, 61) | 83.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=126, 61) | 80.3 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=117, 58) | 81.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=126, 61) | 90.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=115, 57) | 87.7 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=117, 57) | 78.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=126, 61) | 86.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=117, 58) | 84.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=126, 61) | 88.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=126, 61) | 85.2 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=117, 58) | 84.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=115, 57) | 89.5 Percentage of participants |
| Placebo Group | Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=115, 57) | 91.2 Percentage of participants |
Primary
Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling \>100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.
Time frame: Day 0 up to Day 14 post each injection
Population: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema;Post-Any inj (N=126,61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling;PostAny inj (N=126,61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-inj. 1 (N=126, 61) | 6.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema; Post-inj 1 (N=126,61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling; Post-inj. 1 (N=126,61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-inj. 2 (N=117, 58) | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema; Post-inj 2 (N=117,58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-Any inj. (N=126, 61) | 9.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling; Post-inj. 2 (N=117,58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-inj. 3 (N=115, 57) | 2.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema; Post-inj 3 (N=115,57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling; Post-inj. 3 (N=115,57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-Any inj. (N=126, 61) | 5.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post-Any inj. (N=126, 61) | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post Any\-inj. (N=126, 61) | 7.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-Any inj. (N=126, 61) | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-Any inj. (N=126, 61) | 8.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-Any inj. (N=126, 61) | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post Any inj. (N=126, 61) | 9.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-Any inj. (N=126, 61) | 11.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post-Any inj. (N=126, 61) | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-inj. 1 (N=125, 60) | 4.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post-inj. 1 (N=125, 60) | 0.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post-inj. 1 (N=126, 61) | 5.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-inj. 1 (N=126, 61) | 1.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-inj. 1 (N=126, 61) | 7.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post-inj. 1 (N=126, 61) | 7.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post inj. 1 (N=126, 61) | 0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-inj. 1 (N=126, 61) | 9.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-inj. 2 (N=117, 58) | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post-inj. 2 (N=117, 58) | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-inj. 2 (N=117, 58) | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-inj. 2 (N=117, 58) | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post-inj. 2 (N=117, 58) | 1.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-inj. 2 (N=117, 58) | 2.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post-inj. 2 (N=117, 58) | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-inj. 3 (N=113, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post inj. 3 (N=113, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post-inj. 3 (N=115, 57) | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-inj. 3 (N=115, 57) | 0.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-Any inj. (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-Any inj. (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema;Post-Any inj (N=126,61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-inj. 1 (N=125, 60) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling;PostAny inj (N=126,61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-inj. 1 (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post-inj. 1 (N=125, 60) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post-inj. 1 (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema; Post-inj 1 (N=126,61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-inj. 1 (N=126, 61) | 1.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling; Post-inj. 1 (N=126,61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-inj. 2 (N=117, 58) | 3.4 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-inj. 1 (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema; Post-inj 2 (N=117,58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post-inj. 1 (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling; Post-inj. 2 (N=117,58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Pain; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post inj. 1 (N=126, 61) | 1.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Pain; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Erythema; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Asthenia; Post-inj. 1 (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Erythema; Post-inj 3 (N=115,57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Injection-site Swelling; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Asthenia; Post inj. 1 (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Inj.-site Swelling; Post-inj. 3 (N=115,57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-Any inj. (N=126, 61) | 1.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-inj. 2 (N=117, 58) | 1.7 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Fever; Post-inj. 3 (N=113, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post Any\-inj. (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-Any inj. (N=126, 61) | 1.6 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-inj. 3 (N=115, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Malaise; Post-Any inj. (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Headache; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Malaise; Post-Any inj. (N=126, 61) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Fever; Post inj. 3 (N=113, 57) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Myalgia; Post Any inj. (N=126, 61) | 4.9 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Headache; Post-inj. 2 (N=117, 58) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo | Grade 3 Myalgia; Post-Any inj. (N=126, 61) | 1.6 Percentage of participants |
Primary
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=125,61) | 3.23 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=117,58) | 3.15 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=115,57) | 2.64 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=126,61) | 3.53 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=117,58) | 3.83 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=115,57) | 2.38 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=126,61) | 4.35 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=117,58) | 3.97 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=115,57) | 3.39 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=126,61) | 6.46 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=117,57) | 5.16 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=115,57) | 6.11 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=117,57) | 1.15 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=125,61) | 1.23 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=126,61) | 1.36 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=117,58) | 1.26 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=126,61) | 1.27 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=115,57) | 1.18 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=117,58) | 1.13 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=126,61) | 1.23 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=115,57) | 1.44 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=117,58) | 1.17 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=115,57) | 1.22 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=115,57) | 1.05 Titer ratio |
Primary
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=125, 61) | 605 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=126, 61) | 184 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=117, 58) | 556 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=115, 57) | 461 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=126, 61) | 204 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=126, 61) | 720 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=117, 58) | 787 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=115, 57) | 484 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=126, 61) | 219 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=126, 61) | 951 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=117, 58) | 846 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=115, 57) | 709 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre injection 1 (N=126, 61) | 55.4 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=126, 61) | 358 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=117, 57) | 289 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=115, 57) | 336 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=115, 57) | 91.9 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=126, 61) | 216 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=126, 61) | 234 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=125, 61) | 288 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre injection 1 (N=126, 61) | 62.0 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=117, 58) | 294 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=126, 61) | 293 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=115, 57) | 268 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=117, 57) | 72.8 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=126, 61) | 243 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=117, 58) | 249 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=126, 61) | 300 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=126, 61) | 78.7 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=117, 58) | 288 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=115, 57) | 268 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=115, 57) | 258 Titers (1/dilutions) |
Secondary
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Pre-injection 1 (N=113, 56) | 96.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 1 (N=113, 56) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 2 (N=104, 53) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-injection 1 (N=113, 56) | 93.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 1 (N=113, 56) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 2 (N=104, 53) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-injection 1 (N=113, 56) | 92.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 1 (N=113, 56) | 96.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 2 (N=104, 53) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Pre-injection 1 (N=113, 56) | 84.1 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 1 (N=113, 56) | 95.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 2 (N=104, 53) | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 3 (N=102, 52) | 90.4 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Pre-injection 1 (N=113, 56) | 96.4 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-injection 1 (N=113, 56) | 91.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 1 (N=113, 56) | 96.4 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Pre-injection 1 (N=113, 56) | 83.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 2 (N=104, 53) | 94.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 1 (N=113, 56) | 94.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 3 (N=102, 52) | 98.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 2 (N=104, 53) | 84.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-injection 1 (N=113, 56) | 92.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 2 (N=104, 53) | 88.7 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 1 (N=113, 56) | 94.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 1 (N=113, 56) | 85.7 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 2 (N=104, 53) | 90.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 3 (N=102, 52) | 94.2 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 3 (N=102, 52) | 96.2 Percentage of participants |
Secondary
Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=113, 56) | 92.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=112, 56) | 96.4 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=104, 53) | 99.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=113, 56) | 92.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=113, 56) | 98.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=104, 53) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=113, 56) | 94.7 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=113, 56) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=104, 53) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=113, 56) | 85.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=113, 56) | 98.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=104, 52) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=102, 52) | 100.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=102, 52) | 90.4 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=113, 56) | 87.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=113, 56) | 94.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=112, 56) | 89.3 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=113, 56) | 87.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=104, 53) | 88.7 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=113, 56) | 96.4 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=102, 52) | 94.2 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=104, 52) | 86.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=113, 56) | 94.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=104, 53) | 92.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=113, 56) | 94.6 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=113, 56) | 91.1 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=104, 53) | 92.5 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=102, 52) | 96.2 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=102, 52) | 98.1 Percentage of participants |
Secondary
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 1 (N=13, 5) | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 2 (N=13, 5) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 3 (N=13, 5) | 100.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 1 (N=13, 5) | 84.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 2 (N=13, 5) | 84.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 3 (N=13, 5) | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 1 (N=13, 5) | 53.8 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 2 (N=13, 5) | 84.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 3 (N=13, 5) | 76.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 1 (N=13, 5) | 38.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 2 (N=13, 5) | 61.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 3 (N=13, 5) | 76.9 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 1 serotype; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | All 4 serotypes; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 3 serotypes; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo | At least 2 serotypes; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
Secondary
Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=13, 5) | 46.2 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=13, 5) | 61.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=13, 5) | 76.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=13, 5) | 61.5 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=13, 5) | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post injection 3 (N=13, 5) | 76.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=13, 5) | 84.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=13, 5) | 84.6 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=13, 5) | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=13, 5) | 76.9 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=13, 5) | 92.3 Percentage of participants |
| CYD Dengue Vaccine Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=13, 5) | 100.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=13, 5) | 0.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=13, 5) | 20.0 Percentage of participants |
| Placebo Group | Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post injection 3 (N=13, 5) | 20.0 Percentage of participants |
Secondary
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=112,56) | 3.24 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=104,53) | 2.93 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=102,52) | 2.31 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=113,56) | 3.30 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=104,53) | 3.09 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=102,52) | 1.91 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=113,56) | 3.92 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=104,53) | 3.32 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=102,52) | 2.71 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=113,56) | 5.80 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=104,52) | 4.86 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=102,52) | 5.18 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=104,52) | 1.17 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=112,56) | 1.22 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=113,56) | 1.34 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=104,53) | 1.29 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=113,56) | 1.28 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=102,52) | 1.10 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=104,53) | 1.15 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=113,56) | 1.20 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=102,52) | 1.43 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=104,53) | 1.19 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=102,52) | 1.17 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=102,52) | 1.00 Titer ratio |
Secondary
Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=13,5) | 3.10 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=13,5) | 5.64 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=13,5) | 7.43 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=13,5) | 6.41 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=13,5) | 21.4 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=13,5) | 13.4 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=13,5) | 10.8 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=13,5) | 16.6 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=13,5) | 19.7 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=13,5) | 16.4 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=13,5) | 13.7 Titer ratio |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=13,5) | 22.2 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 2/Pre-inj. 1 (N=13,5) | 1.00 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 1/Pre-inj. 1 (N=13,5) | 1.40 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 1/Pre-inj. 1 (N=13,5) | 1.58 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 2/Pre-inj. 1 (N=13,5) | 1.00 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 1/Pre-inj. 1 (N=13,5) | 1.19 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-inj. 3/Pre-inj. 1 (N=13,5) | 2.35 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 2/Pre-inj. 1 (N=13,5) | 1.00 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 1/Pre-inj. 1 (N=13,5) | 1.65 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-inj. 3/Pre-inj. 1 (N=13,5) | 1.46 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 2/Pre-inj. 1 (N=13,5) | 1.00 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-inj. 3/Pre-inj. 1 (N=13,5) | 1.94 Titer ratio |
| Placebo Group | Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-inj. 3/Pre-inj. 1 (N=13,5) | 1.79 Titer ratio |
Secondary
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=113, 56) | 279 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=112, 56) | 925 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=104, 53) | 807 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=102, 52) | 636 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=113, 56) | 312 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=113, 56) | 1030 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=104, 53) | 1010 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=102, 52) | 624 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=113, 56) | 338 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=113, 56) | 1324 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=104, 53) | 1131 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=102, 52) | 912 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=113, 56) | 73.1 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=113, 56) | 424 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=104, 52) | 346 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=102, 52) | 387 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=102, 52) | 117 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=113, 56) | 329 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=113, 56) | 302 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=112, 56) | 401 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=113, 56) | 77.6 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=104, 53) | 432 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=113, 56) | 405 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=102, 52) | 362 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=104, 52) | 94.2 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=113, 56) | 344 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=104, 53) | 361 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=113, 56) | 413 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=113, 56) | 99.1 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=104, 53) | 422 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=102, 52) | 368 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=102, 52) | 357 Titers (1/dilutions) |
Secondary
Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo
Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with \<10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.
Time frame: Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)
Population: Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=13, 5) | 15.5 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=13, 5) | 28.2 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=13, 5) | 37.1 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=13, 5) | 32.1 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=13, 5) | 107 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=13, 5) | 66.8 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=13, 5) | 53.8 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=13, 5) | 83.1 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=13, 5) | 98.6 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=13, 5) | 81.8 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=13, 5) | 68.4 Titers (1/dilutions) |
| CYD Dengue Vaccine Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=13, 5) | 111 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 3 (N=13, 5) | 7.29 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 1 (N=13, 5) | 7.01 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 2 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 1 (N=13, 5) | 5.96 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 1; Post-injection 3 (N=13, 5) | 11.8 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 2 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Pre-injection 1 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 2 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 1 (N=13, 5) | 8.27 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 4; Post-injection 1 (N=13, 5) | 5.96 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 2 (N=13, 5) | 5.00 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 3; Post-injection 3 (N=13, 5) | 9.72 Titers (1/dilutions) |
| Placebo Group | Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo | Serotype 2; Post-injection 3 (N=13, 5) | 8.93 Titers (1/dilutions) |