Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector
Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01765426
Collaborator
National Institutes of Health (NIH) (NIH)
67
2
4
16.3
33.5
2.1
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the safety, tolerability and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] when administered intradermally in varied dosing schedules and via different methods of administration (conventional needle/syringe versus needle-free PharmaJet® injector).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.
Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).
Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.
Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.
Study Design
Study Type:
Interventional
Actual Enrollment
:
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Phase 1b, Partial-Blind, Parallel Group, Randomized Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine (DENVax) Administered Intradermally Using Needle or a Needle-Free PharmaJet® Injector in Healthy Adults
Actual Study Start Date
:
Feb 15, 2013
Actual Primary Completion Date
:
Jun 26, 2014
Actual Study Completion Date
:
Jun 26, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: TDV using PharmaJet® Injector Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
Biological: TDV
TDV suspension for intradermal administration
Drug: Placebo
Phosphate buffered saline (PBS)
|
| Experimental: Group 2: TDV using PharmaJet® Injector TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
Biological: TDV
TDV suspension for intradermal administration
Drug: Placebo
Phosphate buffered saline (PBS)
|
| Experimental: Group 3: TDV using Needle and Syringe TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. |
Biological: TDV
TDV suspension for intradermal administration
Drug: Placebo
Phosphate buffered saline (PBS)
|
| Experimental: Group 4: TDV using PharmaJet® Injector TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
Biological: TDV
TDV suspension for intradermal administration
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff [28 Days after each dose]
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
- Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity [28 Days after each dose]
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.
- Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity [14 days after each dose]
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
- Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity [14 days after each dose]
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.
- Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity [28 Days after each dose]
An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.
- Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) [118 Days]
The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention.
- Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection [Day 28]
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
- Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection [Day 118]
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
- Percentage of Participants With Unsolicited Vaccine-Related SAEs [Dose 1 until 28 days after Dose 2 (Up to Day 118)]
A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.
Secondary Outcome Measures
- Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes [Days 0, 28, 90, 118 and 270]
- Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 [Days 90 and 270]
Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.
- Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination [Day 0 to Day 104]
A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
In good health as determined by medical history and physical examination (including blood pressure and heart rate).
-
Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen.
-
Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception.
-
Body Mass Index (BMI) ≤ 35 kg/m^2.
Exclusion Criteria:
-
Any Grade 2 or above abnormality in the screening laboratory tests.
-
History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease.
-
Seropositivity to dengue or West Nile virus.
-
Extensive scarring or tattoo (> 50%) on arms, shoulders, neck face and head.
-
History of significant dermatologic disease in the last 6 months.
-
Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 vaccinations.
-
Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening.
-
Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month prior to the first vaccination.
-
Use of any prescribed medication 7 days before the first injection.
-
Previous vaccination in a clinical study or with an approved product against Dengue Fever, Yellow Fever and or Japanese Encephalitis.
-
Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy in the last 6 months.
-
Planned donation of blood during the period of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas Medical Branch | Galveston | Texas | United States | 77555 |
| 2 | Group Health Research Institute | Seattle | Washington | United States | 98101 |
Sponsors and Collaborators
- Takeda
- National Institutes of Health (NIH)
Investigators
- Study Director: Medical Director Clinical Science, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT01765426
Other Study ID Numbers:
- 11-0049
- U1111-1178-6503
First Posted:
Jan 10, 2013
Last Update Posted:
Jul 18, 2019
Last Verified:
Jul 1, 2019
Keywords provided by Takeda
Study Results
Participant Flow
| Recruitment Details | Participants took part in the study at 2 investigative sites in the United States from 15 February 2013 (First participant signed Informed Consent Form) to 26 June 2014 (date of last participant's visit/contact). |
|---|---|
| Pre-assignment Detail | Healthy Volunteers were enrolled equally in 1 of 4 treatment groups: Group 1 (2 doses), Group 2 (2 doses) Group 4 (3 doses) of Tetravalent Dengue Vaccine (TDV) using PharmaJet® Injector and Group 3 (2 doses) TDV using needle and syringe. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Period Title: Overall Study | ||||
| STARTED | 18 | 17 | 17 | 15 |
| Completed All Vaccinations | 17 | 16 | 17 | 15 |
| COMPLETED | 18 | 16 | 17 | 15 |
| NOT COMPLETED | 0 | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | Total of all reporting groups |
| Overall Participants | 18 | 17 | 17 | 15 | 67 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
29.3
(8.47)
|
32.4
(8.87)
|
30.1
(7.90)
|
27.5
(6.84)
|
29.9
(8.10)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
5
27.8%
|
7
41.2%
|
5
29.4%
|
9
60%
|
26
38.8%
|
| Male |
13
72.2%
|
10
58.8%
|
12
70.6%
|
6
40%
|
41
61.2%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| Hispanic |
1
5.6%
|
0
0%
|
0
0%
|
3
20%
|
4
6%
|
| Non-Hispanic |
17
94.4%
|
17
100%
|
17
100%
|
12
80%
|
63
94%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| Asian |
1
5.6%
|
1
5.9%
|
2
11.8%
|
0
0%
|
4
6%
|
| Black or African American |
4
22.2%
|
0
0%
|
0
0%
|
1
6.7%
|
5
7.5%
|
| White |
13
72.2%
|
14
82.4%
|
13
76.5%
|
12
80%
|
52
77.6%
|
| Multi-Racial |
0
0%
|
1
5.9%
|
2
11.8%
|
2
13.3%
|
5
7.5%
|
| Other |
0
0%
|
1
5.9%
|
0
0%
|
0
0%
|
1
1.5%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
18
100%
|
17
100%
|
17
100%
|
15
100%
|
67
100%
|
| Weight (kg) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg] |
78.77
(20.349)
|
81.19
(15.673)
|
76.72
(13.672)
|
73.73
(8.939)
|
77.73
(15.354)
|
| Height (cm) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [cm] |
174.47
(8.934)
|
177.58
(9.891)
|
179.77
(8.833)
|
169.13
(10.593)
|
175.41
(10.114)
|
| Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [kg/m^2] |
25.89
(6.458)
|
25.73
(4.516)
|
23.66
(3.406)
|
25.93
(3.743)
|
25.29
(4.733)
|
| Seropositivity Status at Baseline (participants) [Number] | |||||
| Seropositive |
1
5.6%
|
4
23.5%
|
1
5.9%
|
2
13.3%
|
8
11.9%
|
| Seronegative |
17
94.4%
|
13
76.5%
|
16
94.1%
|
13
86.7%
|
59
88.1%
|
Outcome Measures
| Title | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. |
| Time Frame | 28 Days after each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Edema, Grade 0 (None) |
16.7
92.8%
|
11.8
69.4%
|
11.8
69.4%
|
13.3
88.7%
|
| Edema, Any Severity >Grade 0 |
83.3
462.8%
|
88.2
518.8%
|
88.2
518.8%
|
86.7
578%
|
| Edema, Grade 1 (Mild) |
77.8
432.2%
|
82.4
484.7%
|
76.5
450%
|
66.7
444.7%
|
| Edema, Grade 2 (Moderate) |
5.6
31.1%
|
5.9
34.7%
|
11.8
69.4%
|
20.0
133.3%
|
| Erythema, Grade 0 (None) |
11.1
61.7%
|
0
0%
|
0
0%
|
6.7
44.7%
|
| Erythema, Any Severity >Grade 0 |
88.9
493.9%
|
100.0
588.2%
|
100.0
588.2%
|
93.3
622%
|
| Erythema, Grade 1 (Mild) |
55.6
308.9%
|
23.5
138.2%
|
29.4
172.9%
|
20.0
133.3%
|
| Erythema, Grade 2 (Moderate) |
33.3
185%
|
70.6
415.3%
|
64.7
380.6%
|
60.0
400%
|
| Erythema, Grade 3 (Severe) |
0
0%
|
5.9
34.7%
|
5.9
34.7%
|
13.3
88.7%
|
| Itching, Grade 0 (None) |
100.0
555.6%
|
88.2
518.8%
|
76.5
450%
|
80.0
533.3%
|
| Itching, Any Severity >Grade 0 |
0
0%
|
11.8
69.4%
|
23.5
138.2%
|
20.0
133.3%
|
| Itching, Grade 1 (Mild) |
0
0%
|
11.8
69.4%
|
23.5
138.2%
|
20.0
133.3%
|
| Pain, Grade 0 (None) |
38.9
216.1%
|
41.2
242.4%
|
64.7
380.6%
|
53.3
355.3%
|
| Pain, Any Severity >Grade 0 |
61.1
339.4%
|
58.8
345.9%
|
35.3
207.6%
|
46.7
311.3%
|
| Pain, Grade 1 (Mild) |
61.1
339.4%
|
52.9
311.2%
|
35.3
207.6%
|
40.0
266.7%
|
| Pain, Grade 2 (Moderate) |
0
0%
|
5.9
34.7%
|
0
0%
|
6.7
44.7%
|
| Title | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade. |
| Time Frame | 28 Days after each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Any Severity |
83.3
462.8%
|
76.5
450%
|
88.2
518.8%
|
80.0
533.3%
|
| Grade 1 (Mild) |
22.2
123.3%
|
35.3
207.6%
|
52.9
311.2%
|
53.3
355.3%
|
| Grade 2 (Moderate) |
44.4
246.7%
|
23.5
138.2%
|
17.6
103.5%
|
20.0
133.3%
|
| Grade 3 (Severe) |
11.1
61.7%
|
17.6
103.5%
|
5.9
34.7%
|
6.7
44.7%
|
| Grade 4 (Life Threatening) |
5.6
31.1%
|
0
0%
|
11.8
69.4%
|
0
0%
|
| Title | Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. |
| Time Frame | 14 days after each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Temperature, Grade 0 (None) |
94.4
524.4%
|
100.0
588.2%
|
88.2
518.8%
|
100.0
666.7%
|
| Temperature, Any Severity >Grade 0 |
5.6
31.1%
|
0
0%
|
11.8
69.4%
|
0
0%
|
| Temperature, Grade 1 (Mild) |
5.6
31.1%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Temperature, Grade 2 (Moderate) |
0
0%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Headache, Grade 0 (None) |
61.1
339.4%
|
29.4
172.9%
|
41.2
242.4%
|
46.7
311.3%
|
| Headache, Any Severity >Grade 0 |
38.9
216.1%
|
70.6
415.3%
|
58.8
345.9%
|
53.3
355.3%
|
| Headache, Grade 1 (Mild) |
22.2
123.3%
|
58.8
345.9%
|
58.8
345.9%
|
46.7
311.3%
|
| Headache, Grade 2 (Moderate) |
16.7
92.8%
|
11.8
69.4%
|
0
0%
|
6.7
44.7%
|
| Muscle Pain, Grade 0 (None) |
88.9
493.9%
|
82.4
484.7%
|
76.5
450%
|
60.0
400%
|
| Muscle Pain, Any Severity >Grade 0 |
11.1
61.7%
|
17.6
103.5%
|
23.5
138.2%
|
40.0
266.7%
|
| Muscle Pain, Grade 1 (Mild) |
5.6
31.1%
|
17.6
103.5%
|
23.5
138.2%
|
40.0
266.7%
|
| Muscle Pain, Grade 2 (Moderate) |
5.6
31.1%
|
0
0%
|
0
0%
|
0
0%
|
| Joint Pain, Grade 0 (None) |
88.9
493.9%
|
88.2
518.8%
|
88.2
518.8%
|
86.7
578%
|
| Joint Pain, Any Severity >Grade 0 |
11.1
61.7%
|
11.8
69.4%
|
11.8
69.4%
|
13.3
88.7%
|
| Joint Pain, Grade 1 (Mild) |
5.6
31.1%
|
11.8
69.4%
|
5.9
34.7%
|
13.3
88.7%
|
| Joint Pain, Grade 2 (Moderate) |
5.6
31.1%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Eye Pain, Grade 0 (None) |
88.9
493.9%
|
94.1
553.5%
|
88.2
518.8%
|
93.3
622%
|
| Eye Pain, Any Severity >Grade 0 |
11.1
61.7%
|
5.9
34.7%
|
11.8
69.4%
|
6.7
44.7%
|
| Eye Pain, Grade 1 (Mild) |
11.1
61.7%
|
5.9
34.7%
|
11.8
69.4%
|
6.7
44.7%
|
| Increased Sensitivity to Light, Grade 0 |
88.9
493.9%
|
88.2
518.8%
|
88.2
518.8%
|
86.7
578%
|
| Increased Sensitivity to Light, Severity >Grade 0 |
11.1
61.7%
|
11.8
69.4%
|
11.8
69.4%
|
13.3
88.7%
|
| Increased Sensitivity to Light, Grade 1 (Mild) |
11.1
61.7%
|
5.9
34.7%
|
11.8
69.4%
|
13.3
88.7%
|
| Increased Sensitivity to Light, Grade 2 (Moderate) |
0
0%
|
5.9
34.7%
|
0
0%
|
0
0%
|
| Tiredness, Grade 0 (None) |
66.7
370.6%
|
70.6
415.3%
|
47.1
277.1%
|
60.0
400%
|
| Tiredness, Any Severity >Grade 0 |
33.3
185%
|
29.4
172.9%
|
52.9
311.2%
|
40.0
266.7%
|
| Tiredness, Grade 1 (Mild) |
16.7
92.8%
|
23.5
138.2%
|
41.2
242.4%
|
40.0
266.7%
|
| Tiredness, Grade 2 (Moderate) |
16.7
92.8%
|
5.9
34.7%
|
11.8
69.4%
|
0
0%
|
| Rash Anywhere on Body, Grade 0 (None) |
94.4
524.4%
|
88.2
518.8%
|
82.4
484.7%
|
93.3
622%
|
| Rash Anywhere on Body, Any Severity >Grade 0 |
5.6
31.1%
|
11.8
69.4%
|
17.6
103.5%
|
6.7
44.7%
|
| Rash Anywhere on Body, Grade 1 (Mild) |
5.6
31.1%
|
11.8
69.4%
|
11.8
69.4%
|
6.7
44.7%
|
| Rash Anywhere on Body, Grade 2 (Moderate) |
0
0%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Nausea, Grade 0 (None) |
83.3
462.8%
|
88.2
518.8%
|
88.2
518.8%
|
93.3
622%
|
| Nausea, Any Severity >Grade 0 |
16.7
92.8%
|
11.8
69.4%
|
11.8
69.4%
|
6.7
44.7%
|
| Nausea, Grade 1 (Mild) |
16.7
92.8%
|
11.8
69.4%
|
11.8
69.4%
|
6.7
44.7%
|
| Vomiting, Grade 0 (None) |
94.4
524.4%
|
100.0
588.2%
|
94.1
553.5%
|
100
666.7%
|
| Vomiting, Any Severity >Grade 0 |
5.6
31.1%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Vomiting, Grade 1 (Mild) |
5.6
31.1%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Title | Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. |
| Time Frame | 14 days after each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Swelling, Grade 0 (None) |
50.0
277.8%
|
41.2
242.4%
|
35.3
207.6%
|
40.0
266.7%
|
| Swelling, Any Severity >Grade 0 |
50.0
277.8%
|
58.8
345.9%
|
64.7
380.6%
|
60.0
400%
|
| Swelling, Grade 1 (Mild) |
44.4
246.7%
|
47.1
277.1%
|
47.1
277.1%
|
40.0
266.7%
|
| Swelling, Grade 2 (Moderate) |
5.6
31.1%
|
11.8
69.4%
|
17.6
103.5%
|
20.0
133.3%
|
| Redness, Grade 0 |
22.2
123.3%
|
0
0%
|
0
0%
|
20.0
133.3%
|
| Redness, Any Severity >Grade 0 |
77.8
432.2%
|
100
588.2%
|
100.0
588.2%
|
80.0
533.3%
|
| Redness, Grade 1 (Mild) |
44.4
246.7%
|
29.4
172.9%
|
23.5
138.2%
|
13.3
88.7%
|
| Redness, Grade 2 (Moderate) |
33.3
185%
|
64.7
380.6%
|
64.7
380.6%
|
46.7
311.3%
|
| Redness, Grade 3 (Severe) |
0
0%
|
5.9
34.7%
|
11.8
69.4%
|
20.0
133.3%
|
| Itching, Grade 0 (None) |
66.7
370.6%
|
82.4
484.7%
|
47.1
277.1%
|
73.3
488.7%
|
| Itching, Any Severity >Grade 0 |
33.3
185%
|
17.6
103.5%
|
52.9
311.2%
|
26.7
178%
|
| Itching, Grade 1 (Mild) |
33.3
185%
|
11.8
69.4%
|
52.9
311.2%
|
26.7
178%
|
| Itching, Grade 2 (Moderate) |
0
0%
|
5.9
34.7%
|
0
0%
|
0
0%
|
| Pain, Grade 0 (None) |
72.2
401.1%
|
52.9
311.2%
|
76.5
450%
|
33.3
222%
|
| Pain, Any Severity >Grade 0 |
27.8
154.4%
|
47.1
277.1%
|
23.5
138.2%
|
66.7
444.7%
|
| Pain, Grade 1 (Mild) |
27.8
154.4%
|
47.1
277.1%
|
23.5
138.2%
|
66.7
444.7%
|
| Title | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity |
|---|---|
| Description | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. |
| Time Frame | 28 Days after each dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Any Severity |
16.7
92.8%
|
17.6
103.5%
|
52.9
311.2%
|
33.3
222%
|
| Grade 1 (Mild) |
11.1
61.7%
|
11.8
69.4%
|
41.2
242.4%
|
33.3
222%
|
| Grade 2 (Moderate) |
5.6
31.1%
|
0
0%
|
11.8
69.4%
|
0
0%
|
| Grade 3 (Severe) |
0
0%
|
5.9
34.7%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) |
|---|---|
| Description | The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention. |
| Time Frame | 118 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Alanine aminotransferase increased |
5.6
31.1%
|
0
0%
|
0
0%
|
0
0%
|
| Aspartate aminotransferase increased |
5.6
31.1%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Blood bilirubin increased |
5.6
31.1%
|
0
0%
|
0
0%
|
0
0%
|
| Blood creatine phosphokinase increased |
5.6
31.1%
|
11.8
69.4%
|
11.8
69.4%
|
0
0%
|
| Occult blood |
0
0%
|
0
0%
|
5.9
34.7%
|
0
0%
|
| Title | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection |
|---|---|
| Description | Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer. |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set included all randomized participants who completed the study without any major protocol violations. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 16 | 13 | 16 | 13 |
| DEN-1 |
75.0
416.7%
|
38.5
226.5%
|
62.5
367.6%
|
84.6
564%
|
| DEN-2 |
62.5
347.2%
|
61.5
361.8%
|
50.0
294.1%
|
76.9
512.7%
|
| DEN-3 |
56.3
312.8%
|
23.1
135.9%
|
31.3
184.1%
|
46.2
308%
|
| DEN-4 |
31.3
173.9%
|
23.1
135.9%
|
50.0
294.1%
|
38.5
256.7%
|
| Title | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection |
|---|---|
| Description | Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer. |
| Time Frame | Day 118 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set included all randomized participants who completed the study without any major protocol violations. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 16 | 13 | 16 | 13 |
| DEN-1 |
75.0
416.7%
|
69.2
407.1%
|
87.5
514.7%
|
84.6
564%
|
| DEN-2 |
68.8
382.2%
|
69.2
407.1%
|
62.5
367.6%
|
84.6
564%
|
| DEN-3 |
75.0
416.7%
|
69.2
407.1%
|
87.5
514.7%
|
84.6
564%
|
| DEN-4 |
31.3
173.9%
|
30.8
181.2%
|
81.3
478.2%
|
53.8
358.7%
|
| Title | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes |
|---|---|
| Description | |
| Time Frame | Days 0, 28, 90, 118 and 270 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set included all randomized participants who completed the study without any major protocol violations. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 16 | 13 | 16 | 13 |
| Day 0 DEN-1 |
5.0
|
5.0
|
5.0
|
5.0
|
| Day 0 DEN-2 |
5.0
|
5.0
|
5.0
|
5.0
|
| Day 0 DEN-3 |
5.0
|
5.0
|
5.0
|
5.0
|
| Day 0 DEN-4 |
5.0
|
5.0
|
5.0
|
5.0
|
| Day 28 DEN-1 |
28.3
|
10.5
|
27.1
|
29.0
|
| Day 28 DEN-2 |
293.4
|
311.6
|
146.7
|
1006.9
|
| Day 28 DEN-3 |
32.2
|
11.1
|
10.0
|
19.0
|
| Day 28 DEN-4 |
13.5
|
11.7
|
32.2
|
20.0
|
| Day 90 DEN-1 |
29.5
|
26.1
|
28.9
|
19.0
|
| Day 90 DEN-2 |
174.5
|
311.6
|
60.4
|
560.1
|
| Day 90 DEN-3 |
30.2
|
22.3
|
11.9
|
19.0
|
| Day 90 DEN-4 |
7.1
|
11.7
|
20.9
|
19.0
|
| Day 118 DEN-1 |
25.9
|
21.1
|
60.4
|
21.1
|
| Day 118 DEN-2 |
160.0
|
220.3
|
89.2
|
429.1
|
| Day 118 DEN-3 |
30.8
|
19.0
|
36.7
|
32.3
|
| Day 118 DEN-4 |
8.4
|
10.8
|
54.2
|
22.3
|
| Day 270 DEN-1 |
16.8
|
12.4
|
24.8
|
10.5
|
| Day 270 DEN-2 |
118.1
|
173.3
|
54.2
|
265.5
|
| Day 270 DEN-3 |
21.8
|
14.5
|
14.8
|
14.5
|
| Day 270 DEN-4 |
8.4
|
10.0
|
28.3
|
13.8
|
| Title | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 |
|---|---|
| Description | Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer. |
| Time Frame | Days 90 and 270 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set included all randomized participants who completed the study without any major protocol violations. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 16 | 13 | 16 | 13 |
| Day 90 DEN-1 |
68.8
382.2%
|
61.5
361.8%
|
62.5
367.6%
|
76.9
512.7%
|
| Day 90 DEN-2 |
75.0
416.7%
|
69.2
407.1%
|
43.8
257.6%
|
84.6
564%
|
| Day 90 DEN-3 |
62.5
347.2%
|
61.5
361.8%
|
43.8
257.6%
|
61.5
410%
|
| Day 90 DEN-4 |
18.8
104.4%
|
30.8
181.2%
|
56.3
331.2%
|
46.2
308%
|
| Day 270 DEN-1 |
62.5
347.2%
|
46.2
271.8%
|
75.0
441.2%
|
61.5
410%
|
| Day 270 DEN-2 |
62.5
347.2%
|
69.2
407.1%
|
50.0
294.1%
|
84.6
564%
|
| Day 270 DEN-3 |
68.8
382.2%
|
53.8
316.5%
|
75.0
441.2%
|
69.2
461.3%
|
| Day 270 DEN-4 |
25.0
138.9%
|
23.1
135.9%
|
75.0
441.2%
|
46.2
308%
|
| Title | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination |
|---|---|
| Description | A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported. |
| Time Frame | Day 0 to Day 104 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| DEN-1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| DEN-2 |
38.9
216.1%
|
23.5
138.2%
|
23.5
138.2%
|
53.3
355.3%
|
| DEN-3 |
5.6
31.1%
|
5.9
34.7%
|
0
0%
|
0
0%
|
| DEN-4 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With Unsolicited Vaccine-Related SAEs |
|---|---|
| Description | A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes. |
| Time Frame | Dose 1 until 28 days after Dose 2 (Up to Day 118) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. |
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector |
|---|---|---|---|---|
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. |
| Measure Participants | 18 | 17 | 17 | 15 |
| Number [percentage of participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. Events meeting the protocol-specified seriousness criteria were reported as SAEs. | |||||||
| Arm/Group Title | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector | ||||
| Arm/Group Description | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90. | TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90. | ||||
All Cause Mortality |
||||||||
| Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/18 (83.3%) | 13/17 (76.5%) | 15/17 (88.2%) | 12/15 (80%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Lymphadenopathy | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Eye disorders | ||||||||
| Eye irritation | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Abdominal pain | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Abdominal pain upper | 1/18 (5.6%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Aphthous stomatitis | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Diarrhoea | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Dyspepsia | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Flatulence | 0/18 (0%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Gastrointestinal disorder | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Gingival pain | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Toothache | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Vomiting | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| General disorders | ||||||||
| Injection site haematoma | 2/18 (11.1%) | 0/17 (0%) | 3/17 (17.6%) | 0/15 (0%) | ||||
| Injection site warmth | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 3/15 (20%) | ||||
| Vessel puncture site haematoma | 2/18 (11.1%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Vessel puncture site pain | 1/18 (5.6%) | 1/17 (5.9%) | 2/17 (11.8%) | 0/15 (0%) | ||||
| Chest pain | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Chills | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Feeling abnormal | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Influenza like illness | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Injection site discolouration | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Injection site haemorrhage | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 1/15 (6.7%) | ||||
| Injection site pain | 1/18 (5.6%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Malaise | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Vessel puncture site haemorrhage | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Pain | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Pyrexia | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Biliary colic | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Hyperbilirubinaemia | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Immune system disorders | ||||||||
| Seasonal allergy | 1/18 (5.6%) | 0/17 (0%) | 2/17 (11.8%) | 1/15 (6.7%) | ||||
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 4/18 (22.2%) | 4/17 (23.5%) | 4/17 (23.5%) | 3/15 (20%) | ||||
| Urinary tract infection | 3/18 (16.7%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Viral infection | 1/18 (5.6%) | 1/17 (5.9%) | 1/17 (5.9%) | 1/15 (6.7%) | ||||
| Chlamydial infection | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Folliculitis | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Gingival infection | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Pharyngitis | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 2/15 (13.3%) | ||||
| Pharyngitis streptococcal | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Arthropod bite | 2/18 (11.1%) | 2/17 (11.8%) | 0/17 (0%) | 2/15 (13.3%) | ||||
| Contusion | 1/18 (5.6%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Excoriation | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 2/15 (13.3%) | ||||
| Joint sprain | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Laceration | 2/18 (11.1%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Muscle strain | 1/18 (5.6%) | 0/17 (0%) | 2/17 (11.8%) | 0/15 (0%) | ||||
| Scratch | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Sunburn | 2/18 (11.1%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Thermal burn | 1/18 (5.6%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Investigations | ||||||||
| Blood creatine phosphokinase increased | 1/18 (5.6%) | 2/17 (11.8%) | 2/17 (11.8%) | 0/15 (0%) | ||||
| Alanine aminotransferase increased | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Aspartate aminotransferase increased | 1/18 (5.6%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Blood bilirubin increased | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Occult blood | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 1/15 (6.7%) | ||||
| Back pain | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Groin pain | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Muscle spasms | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Muscle twitching | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Musculoskeletal stiffness | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Myalgia | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Neck pain | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Pain in extremity | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 2/15 (13.3%) | ||||
| Rotator cuff syndrome | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Skin papilloma | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Nervous system disorders | ||||||||
| Headache | 2/18 (11.1%) | 1/17 (5.9%) | 0/17 (0%) | 2/15 (13.3%) | ||||
| Dizziness | 2/18 (11.1%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Hypoaesthesia | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Syncope | 1/18 (5.6%) | 0/17 (0%) | 2/17 (11.8%) | 0/15 (0%) | ||||
| Psychiatric disorders | ||||||||
| Insomnia | 1/18 (5.6%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Dysuria | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Haematuria | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Micturition urgency | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Proteinuria | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/18 (0%) | 0/17 (0%) | 3/17 (17.6%) | 0/15 (0%) | ||||
| Oropharyngeal pain | 2/18 (11.1%) | 0/17 (0%) | 2/17 (11.8%) | 0/15 (0%) | ||||
| Nasal congestion | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
| Respiratory tract congestion | 1/18 (5.6%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Rhinorrhoea | 1/18 (5.6%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Sinus congestion | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Acne | 0/18 (0%) | 0/17 (0%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Blister | 0/18 (0%) | 1/17 (5.9%) | 1/17 (5.9%) | 0/15 (0%) | ||||
| Ecchymosis | 0/18 (0%) | 1/17 (5.9%) | 0/17 (0%) | 0/15 (0%) | ||||
| Ingrown hair | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Pruritus | 1/18 (5.6%) | 0/17 (0%) | 0/17 (0%) | 0/15 (0%) | ||||
| Urticaria | 0/18 (0%) | 0/17 (0%) | 0/17 (0%) | 1/15 (6.7%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor is permitted to protect any proprietary information and to provide comments based on information from other studies that may not be available to the Investigator.
Results Point of Contact
| Name/Title | Medical Director, Clinical Science |
|---|---|
| Organization | Takeda |
| Phone | +1-877-825-3327 |
| trialdisclosures@takeda.com |
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT01765426
Other Study ID Numbers:
- 11-0049
- U1111-1178-6503
First Posted:
Jan 10, 2013
Last Update Posted:
Jul 18, 2019
Last Verified:
Jul 1, 2019