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The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.
The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue.
The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo:
In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group.
This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. |
|
| TDV Lot 1 | Experimental | Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
|
| TDV Lot 2 | Experimental | Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
|
| TDV Lot 3 | Experimental | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-003 | Biological | TDV subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | 1 month post second dose (Day 120) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | 1 month post second dose (Day 120) and 6 months post second dose (Day 270) |
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Inclusion Criteria:
Exclusion Criteria:
Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
Known hypersensitivity or allergy to any of the vaccine components (including excipients of the investigational vaccine or placebo).
Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including:
Has abnormalities of splenic or thymic function.
Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in meters^2]).
Has history of substance or alcohol abuse within the past 2 years.
Had previous and planned vaccination (during the trial conduct) against any flavivirus including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile (WN) fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimal Research | Huntsville | Alabama | 35802 | United States | ||
| Anaheim Clinical Trials, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40099800 | Derived | Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27. | |
| 37884415 | Derived | Tricou V, Winkle PJ, Tharenos LM, Rauscher M, Escudero I, Hoffman E, LeFevre I, Borkowski A, Wallace D. Consistency of immunogenicity in three consecutive lots of a tetravalent dengue vaccine candidate (TAK-003): A randomized placebo-controlled trial in US adults. Vaccine. 2023 Nov 13;41(47):6999-7006. doi: 10.1016/j.vaccine.2023.09.049. Epub 2023 Oct 24. |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Healthy participants were enrolled in 2:2:2:1 ratio into one of the four trial groups and received either Tetravalent Dengue Vaccine (TDV) lot 1, TDV Lot 2, TDV Lot 3 or Placebo for the investigation of lot to lot consistency of three consecutive lots.
Participants took part in the study at 14 investigative sites in the United States from 12 February 2018 to 14 January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. |
| FG001 | TDV Lot 1 | Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 29, 2018 | Sep 11, 2020 |
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A double-blind study.
| Placebo | Biological | TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection |
|
| GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | 6 months post second dose (Day 270) |
| Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<25 mm, mild: >25 - ≤50 mm, moderate: >50 - ≤100 mm, severe: >100 mm) and swelling (edema/induration) (<25 mm, mild: >25 - ≤50 mm, moderate: >50 - ≤100 mm, severe: >100 mm ). The percentages were rounded off to the first decimal place. | Within 7 Days of each Vaccination (day of vaccination + 6 days) |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. | Within 14 Days of each Vaccination (day of vaccination + 13 days) |
| Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | An AE was 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. | Within 28 days (day of vaccination + 27 days) after each vaccination |
| Percentage of Participants With Serious Adverse Events (SAEs) | An SAE was 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 participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. The percentages were rounded off to the first decimal place. | From the first vaccination on Day 1 until the end of the trial (Day 270) |
| 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. The percentages were rounded off to the first decimal place. | From the first vaccination on Day 1 until the end of the trial (Day 270) |
| Anaheim |
| California |
| 92805 |
| United States |
| Advanced Clinical Research | Boise | Idaho | 83704 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| Synexus Limited- Council Bluffs | Council Bluffs | Iowa | 51503 | United States |
| Heartland Research Associates LLC - Augusta | Augusta | Kansas | 67010 | United States |
| Heartland Research Associates LLC | Park City | Kansas | 67219 | United States |
| Optimal Research | Rockville | Maryland | 20850 | United States |
| Synexus Limited - Minneapolis | Edina | Minnesota | 55435 | United States |
| Synexus Limited - St. Louis | St Louis | Missouri | 63141 | United States |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | United States |
| Synexus Limited - Columbus | Columbus | Ohio | 43212 | United States |
| Advanced Clinical Research | Salt Lake City | Utah | 84123 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| FG002 | TDV Lot 2 | Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| FG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
| Received at Least 1 Dose of the IP | Investigational Product (IP) includes TDV and placebo. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Randomized Set included all randomized participants irrespective of whether a dose of the trial vaccine (TDV or placebo) was received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. |
| BG001 | TDV Lot 1 | Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| BG002 | TDV Lot 2 | Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| BG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Height | Number analyzed is the number of participants with data available for height at Baseline. | Mean | Standard Deviation | cm |
| |||||||||
| Weight | Number analyzed is the number of participants with data available for weight at Baseline. | Mean | Standard Deviation | kg |
| |||||||||
| Body Mass Index (BMI) | BMI=Weight (kg)/Height (m^2). | Number analyzed is the number of participants with data available for BMI at Baseline. | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 in the Immunogenicity Subset | GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | Per protocol Set (PPS) included all DENV-naïve participants in immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement and had no major protocol violations.Number of participants analyzed:participants with data available at given timepoint. | Posted | Geometric Mean | 95% Confidence Interval | titer | 1 month post second dose (Day 120) |
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| Secondary | Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes at Days 120 and 270 in the Immunogenicity Subset | Seropositivity was defined as a reciprocal neutralizing titer ≥ 10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | PPS included all DENV-naïve participants in the immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement, and who had no major protocol violations. Number analyzed are participants with data available at the given timepoint. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month post second dose (Day 120) and 6 months post second dose (Day 270) |
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| Secondary | GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270 in the Immunogenicity Subset | GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% [MNT50]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. | Per protocol Set (PPS) included all DENV-naïve participants in immunogenicity subset who received at least 1 dose of trial vaccine, with data available for Baseline (Day 1) and at least 1 post-Baseline immunogenicity measurement and had no major protocol violations.Number of participants analyzed:participants with data available at given timepoint. | Posted | Geometric Mean | 95% Confidence Interval | titer | 6 months post second dose (Day 270) |
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| Secondary | Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity After Each Vaccination | Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<25 mm, mild: >25 - ≤50 mm, moderate: >50 - ≤100 mm, severe: >100 mm) and swelling (edema/induration) (<25 mm, mild: >25 - ≤50 mm, moderate: >50 - ≤100 mm, severe: >100 mm ). The percentages were rounded off to the first decimal place. | Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. Number analyzed are participants with data available for the specific 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) |
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| Secondary | Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity After Each Vaccination | Solicited systemic AEs include fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. Solicited systemic AEs (headache, asthenia, malaise and myalgia) was graded from 0 to 3 by severity; where 0=None, 1=Mild: No interference with daily activity, 2=Moderate: Interference with daily activity, 3=Severe: Prevents daily activity; A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it. The percentages were rounded off to the first decimal place. | Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. Number analyzed are participants with data available for the specific 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) |
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| Secondary | Percentage of Participants With Any Unsolicited Adverse Events (AEs) After Each Vaccination | An AE was 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 participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. Number analyzed is the number of participants with data available for the specific category. | Posted | Number | percentage of participants | Within 28 days (day of vaccination + 27 days) after each vaccination |
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| Secondary | Percentage of Participants With Serious Adverse Events (SAEs) | An SAE was 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 participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. The percentages were rounded off to the first decimal place. | Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. | Posted | Number | percentage of participants | From the first vaccination on Day 1 until the end of the trial (Day 270) |
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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. The percentages were rounded off to the first decimal place. | Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated. | Posted | Number | percentage of participants | From the first vaccination on Day 1 until the end of the trial (Day 270) |
|
All-cause mortality and Serious adverse events: From the first vaccination on Day 1 until the end of the trial (Day 270); Other adverse events: Up to 28 days (Day of vaccination+27 subsequent days) after each vaccination.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Set included all participants who received at least 1 dose of trial vaccine (TDV or placebo). Participants were analyzed as treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. | 1 | 131 | 4 | 131 | 4 | 131 |
| EG001 | TDV Lot 1 | Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. | 0 | 264 | 10 | 264 | 16 | 264 |
| EG002 | TDV Lot 2 | Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. | 0 | 261 | 3 | 261 | 26 | 261 |
| EG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. | 0 | 263 | 3 | 263 | 23 | 263 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Anastomotic ulcer perforation | Gastrointestinal disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Perforation bile duct | Hepatobiliary disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA: 21.0 | Systematic Assessment |
| |
| Infected seroma | Infections and infestations | MedDRA: 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA: 21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA: 21.0 | Systematic Assessment |
| |
| Chemical burn of gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA: 21.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA: 21.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA: 21.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA: 21.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA: 21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Cervix carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA: 21.0 | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA: 21.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA: 21.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA: 21.0 | Systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA: 21.0 | Systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA: 21.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA: 21.0 | Systematic Assessment |
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| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA: 21.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA: 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site bruising | General disorders | MedDRA: 21.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA: 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA: 21.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2019 | Sep 11, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
| D014777 | Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
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| DENV-2 |
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| DENV-3 |
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| DENV-4 |
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| DENV-1 | GMT Ratio | 0.91 | 2-Sided | 95 | 0.60 | 1.38 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-1 | GMT Ratio | 0.63 | 2-Sided | 95 | 0.41 | 0.96 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-2 | GMT Ratio | 1.30 | 2-Sided | 95 | 0.98 | 1.71 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-2 | GMT Ratio | 0.67 | 2-Sided | 95 | 0.51 | 0.88 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-2 | GMT Ratio | 0.86 | 2-Sided | 95 | 0.65 | 1.15 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-3 | GMT Ratio | 1.27 | 2-Sided | 95 | 0.91 | 1.78 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-3 | GMT Ratio | 0.95 | 2-Sided | 95 | 0.68 | 1.33 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-3 | GMT Ratio | 1.22 | 2-Sided | 95 | 0.87 | 1.71 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-4 | GMT Ratio | 0.62 | 2-Sided | 95 | 0.46 | 0.82 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-4 | GMT Ratio | 1.62 | 2-Sided | 95 | 1.22 | 2.17 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| DENV-4 | GMT Ratio | 1.00 | 2-Sided | 95 | 0.75 | 1.35 | ANOVA model was used for analysis, including natural logarithms of titers as a response variable and trial group as a factor. | Equivalence | Equivalence between immune responses of 2 trial groups was established if the 95% CI of the corresponding geometric mean ratio was within pre-specified equivalence margins of 0.5 and 2.0. |
| OG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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| OG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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| OG002 |
| TDV Lot 2 |
Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| OG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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| OG002 | TDV Lot 2 | Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| OG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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| OG003 |
| TDV Lot 3 |
Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| OG003 | TDV Lot 3 | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
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