| Primary | Percentage of Participants Who Are YF and Dengue Virus (DENV)-Naive at Baseline and Are Seroprotected Against YF on Day 30 as Measured by Plaque Reduction Neutralization Test (PRNT) | Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. Immunological naivety to YF and DENV was defined as Baseline reciprocal neutralizing antibody titers <10 for YF and for the 4 dengue serotypes. The 95% CI was calculated using exact Clopper-Pearson method. | Yellow Fever Per-Protocol Set (YF PPS) included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and Day 30, and who had no major protocol violations. Overall number analyzed are participants with data available for analyses at given time point within pre-specified visit window. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 30 | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. | | OG002 | Group 3: TDV + YF-17D/TDV/Placebo | TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00099.5(97.4 to 100.0)
- OG0019.8(6.3 to 14.4)
- OG00299.1(96.9 to 99.9)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Seroprotection Rate Difference | 0.40 | | | 2-Sided | 95 | -1.85 | 2.69 | | | The Newcombe score method was used to compute the 95% CI of the seroprotection rate difference. | | Non-Inferiority | Non-inferiority of the immune response was performed only between YF + TDV (Group 3) and YF + Placebo (Group 1) at Day 120. Non-inferiority between Group 3 and Group 1 was concluded if the upper bound of the 95% CI for the seroprotection rate difference (Group 1 - Group 3) was less than 5%. | |
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| Secondary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline | GMTs of neutralizing antibodies was measured by microneutralization test 50% [MNT50] for each of the 4 dengue serotypes. The 4 DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. | Per-Protocol Set (PPS) included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and >=1 post-Baseline immunogenicity measurement, and who had no major protocol violations.Number analyzed are participants with data available at given time point within pre-specified visit window. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | Pre-second and -third vaccination (Days 90 and 180, respectively); and 1 month post -first, second, and third vaccination (Days 30, 120, and 210, respectively) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. |
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| Secondary | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline | Seropositivity rate was defined as the percentage of seropositive participants as derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. Seropositivity for each dengue serotype were analyzed and was summarized as: DENV-1, DENV-2, DENV-3, and DENV-4. | PPS included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and >=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Number analyzed are participants with data available at given time point within pre-specified visit window. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-second and -third vaccination (Days 90 and 180, respectively); and 1-month post -first, -second, and -third vaccination (Days 30, 120, and 210, respectively) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. |
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| Secondary | Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline | Seropositivity rate was defined as the percentage of seropositive participants, as derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. Seropositivity for multiple dengue serotypes were summarized in the following categories: at least bivalent, at least trivalent and tetravalent. | PPS included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and >=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Number analyzed are participants with data available at given time point within pre-specified visit window. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Pre-second and -third vaccination (Days 90 and 180, respectively); and 1-month post -first, second, and -third vaccination (Days 30, 120, and 210, respectively) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. |
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| Secondary | Percentage of YF and DENV-naive Participants at Baseline Who Are Seroprotected Against YF on Day 210 as Measured by PRNT | Seroprotection was defined as reciprocal anti-YF neutralizing antibody titer ≥10. | PPS included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and >=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Overall number analyzed: participants with data available for analyses at given time point within pre-specified visit window. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1-month post third vaccination (Day 210) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. | | OG002 | Group 3: TDV + YF-17D/TDV/Placebo |
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| Secondary | Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 30 in Participants YF and DENV-Naive at Baseline | Geometric mean titers of YF neutralizing antibodies was measured by plaque reduction neutralization test. | YF PPS included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and Day 30, and who had no major protocol violations. Overall number analyzed are participants with data available for analyses at given time point within pre-specified visit window. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1-month post-first vaccination (Day 30) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. | | OG002 | Group 3: TDV + YF-17D/TDV/Placebo |
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| Secondary | Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 210 in Participants YF and DENV-Naive at Baseline | Geometric mean titers of YF neutralizing antibodies was measured by plaque reduction neutralization test. | PPS included all participants YF and DENV-naïve at Baseline who received >=1 dose of trial vaccine, with data available for Baseline and >=1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Overall number analyzed: participants with data available for analyses at given time point within pre-specified visit window. | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1-month post-third vaccination (Day 210) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. | | OG002 | Group 3: TDV + YF-17D/TDV/Placebo |
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| Secondary | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Solicited local injection site AEs recorded from participant's-diary. Severity grade at injection site for pain: Grade 0 (No Pain), 1 (did not interfere with daily activity), 2 (interference with daily activity with or without treatment) and 3 (prevents daily activity with or without treatment). For erythema: grade 0 (<25 mm), 1 (>25-≤50 mm), 2 (>50-≤100 mm) and 3 (>100 mm). For swelling: grade 0 (<25 mm), 1 (>25-≤50 mm), 2 (>50-≤100 mm) and 3 (>100 mm). Percentages were rounded off for each category. For the first vaccination (Vac.) YF is given in Arm 1 (A1) and TDV is given in Arm 2 (A2). A1 = YF for Group 1, Placebo for Group 2, and YF for Group 3; A2 = Placebo for Group 1, TDV for Group 2, and TDV for Group 3. | Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. Number analyzed are participants with data available for the category. Only categories with at least one participant are reported. | Posted | | Number | | percentage of participants | | Within 7 Days of each Vaccination (day of vaccination + 6 days) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). |
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| Secondary | Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity | Solicited systemic AEs (fever, headache, asthenia, malaise, and myalgia) recorded from participant's-diary. Severity grades for headache are grade 0 (none), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents normal activity with or without treatment). Severity grades for asthenia, malaise and myalgia is grade 0 (none), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity), 3 (severe: prevents daily activity). Fever is defined as greater than or equal to 38º C or 100.4º C. Fever was excluded from the overall count as no severity grading was applied for it. Percentages were rounded off for each category. | Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. Number analyzed are participants with data available for the category. Only categories with at least one participant are reported. | Posted | | Number | | percentage of participants | | Within 14 Days of each Vaccination (day of vaccination + 13 days) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D |
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| Secondary | Percentage of Participants With Any Unsolicited Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. | Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. Number analyzed is the number of participants with data available for analyses at the given timepoint. | Posted | | Number | | percentage of participants | | Within 28 days (day of vaccination + 27 days) after each vaccination | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. | | OG002 | Group 3: TDV + YF-17D/TDV/Placebo | |
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| Secondary | Percentage of Participants With Medically Attended Adverse Events (MAAEs) | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. | Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. | Posted | | Number | | percentage of participants | | From first vaccination (Day 1) through end of study (Day 360) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. | | OG002 | Group 3: TDV + YF-17D/TDV/Placebo | TDV, 0.5 mL, injection, SC plus YF-17D vaccine, 0.5 mL, injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on day 90 (second dose), followed by TDV + YF 17D placebo-matching, 0.5 mL, injection, SC on Day 180. |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event that may require intervention to prevent any of the above mentioned criteria and/or may expose the subject to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. | Safety Set included all randomized participants who received at least 1 dose of the trial vaccines. | Posted | | Number | | percentage of participants | | From first vaccination (Day 1) through end of study (Day 360) | | | | ID | Title | Description |
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| OG000 | Group 1: YF-17D + Placebo/TDV/TDV | YF-17D vaccine, 0.5 mL injection, subcutaneously (SC) plus YF 17D + TDV placebo-matching 0.5 mL, injection, SC on Day 1, followed by TDV, 0.5 mL, injection, SC on Day 90 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 180 (second dose). | | OG001 | Group 2: TDV + Placebo/TDV/YF-17D | TDV, 0.5 mL, injection, SC plus TDV placebo-matching, 0.5 mL injection, SC on Day 1 (first dose), followed by TDV, 0.5 mL, injection, SC on Day 90 (second dose), followed by YF-17D vaccine, 0.5 mL, injection, SC on Day 180. |
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