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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1177-8166 | Registry Identifier | WHO |
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A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine.
Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline [during the screening period or on day of vaccination (Day 0)], then on Days 30, 90 and 120.
The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and placebo, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. |
|
| Group 2 | Experimental | TDV, 0.5 mL, subcutaneous injection in one arm and TDV 0.5 mL, subcutaneous injection in the other arm on Day 0. Placebo, 0.5 mL, subcutaneous injection on Day 90. |
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| Group 3 | Experimental | TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. |
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| Group 4 | Experimental | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
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| Group 5 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Takeda's Tetravalent Dengue Vaccine Candidate (TDV) | Biological | TDV subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported. | Day 0 to Day 104 |
| Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. | For 30 days after each dose (Up to Day 120) |
| Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination. | For 30 days after each dose (Up to Day 120) |
| Rate of Seroconversion to Each of Four Dengue Serotypes | Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported. | various timepoints up to 30 days after each dose (Up to Day 120) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilad Gordon, MD | Inviragen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center of the Rockies | Fort Collins | Colorado | 80528 | United States | ||
| University of Texas Medical Branch |
Participants were enrolled in 1 of 6 treatment groups (GRP). GRP1: 1 dose TDV on Day 0 and 90, GRP2: 2 doses of TDV on Day 0, GRP3: 2 Doses of TDV on Day 0 and 1 dose of TDV on Day 90, GRP4: 1 Dose of TDV New Formula on Day 0 and 90, GRP5: 2 doses of TDV New Formula on Day 0 and 90 and GRP6: 1/10 dose of TDV on Day 0 and 90.
Participants took part in the study at 3 investigative sites in the United States from 23 January 2012 to 10 January 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (D0:TDV,P D90:TDV) | Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90). |
| FG001 | Group 2 (D0:TDV,TDV D90:P) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
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| Group 6 | Experimental | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90. |
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| TDV New Formulation | Biological | TDV New Formulation subcutaneous injection |
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| Placebo | Drug | Placebo subcutaneous injection |
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| New Formulation Placebo | Drug | New Formulation placebo subcutaneous injection |
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| Up to 30 days after the last immunization (Up to Day 120) |
| Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Days 30, 90 and 120 after 1st vaccination |
| Galveston |
| Texas |
| 77555 |
| United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90. |
| FG002 | Group 3 (D0:TDV,TDV D90:TDV) | TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. |
| FG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| FG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| FG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (D0:TDV,P D90:TDV) | Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90). |
| BG001 | Group 2 (DO:TDV,TDV D90:P) | TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90. |
| BG002 | Group 3 (D0:TDV,TDV D90:TDV) | TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. |
| BG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| BG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| BG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | m |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| 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 | Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported | Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported. | Safety population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Day 0 to Day 104 |
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| Secondary | Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations | Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported. | Full Analysis Set included all enrolled participants. | Posted | Number | percentage of participants | various timepoints up to 30 days after each dose (Up to Day 120) |
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| Primary | Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. | Safety Population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | For 30 days after each dose (Up to Day 120) |
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| Primary | Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination. | Safety Population included all enrolled participants who received at least one dose of study drug. | Posted | Number | participants | For 30 days after each dose (Up to Day 120) |
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| Secondary | Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes | Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Days 30, 90 and 120 after 1st vaccination |
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| Primary | Rate of Seroconversion to Each of Four Dengue Serotypes | Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline. | Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point. | Posted | Number | percentage of participants | Up to 30 days after the last immunization (Up to Day 120) |
|
Day 0 to Day 120
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.
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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 | Group 1 (D0:TDV,P D90:TDV) | Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90). | 0 | 25 | 24 | 25 | ||
| EG001 | Group 2 (D0:TDV,TDV D90:P) | TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90. | 0 | 25 | 18 | 25 | ||
| EG002 | Group 3 (D0:TDV,TDV D90:TDV) | TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. | 0 | 24 | 20 | 24 | ||
| EG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. | 0 | 21 | 16 | 21 | ||
| EG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. | 0 | 21 | 17 | 21 | ||
| EG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. | 0 | 24 | 18 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA (14.0) | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (14.0) | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | clinicaltrialregistry@tpna.com |
| Male |
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| Black/African American |
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| Hawaiian/Pacific Islander |
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| Hispanic Or Latino |
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| Other |
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| White |
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| Erythema=0 |
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| Itching=0 |
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| Itching=1 |
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| Pain=0 |
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| Pain=1 |
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| Pain=2 |
|
| OG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
|
|
TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
| OG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
|
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| Group 3 (D0:TDV,TDV D90:TDV) |
TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. |
| OG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
|
|
TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
| OG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG005 | Group 6 (D0:1/10TDV D90:1/10TDV) | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
|
|
| OG003 | Group 4 (D0:TDVN,P D90:TDVN,P) | TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG004 | Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) | TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. |
| OG005 | Group 6 (D0:1/10TDV D90:1/10TDV | 1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90. |
|
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