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Phase 1b Study Investigating Safety & Immunogenicity of TDV Given Intradermally by Needle or Needle-Free PharmaJet Injector

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01765426
First Posted: January 10, 2013
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Takeda
Results First Submitted: November 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Healthy Volunteers
Interventions: Biological: TDV
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.
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.
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.

Participant Flow:   Overall Study
    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
STARTED   18   17   17   15 
Completed All Vaccinations   17   16   17   15 
COMPLETED   18   16   17   15 
NOT COMPLETED   0   1   0   0 
Lost to Follow-up                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis population included all randomized participants.

Reporting Groups
  Description
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.
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 18   17   17   15   67 
Age 
[Units: Years]
Mean (Standard Deviation)
 29.3  (8.47)   32.4  (8.87)   30.1  (7.90)   27.5  (6.84)   29.9  (8.10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  27.8%      7  41.2%      5  29.4%      9  60.0%      26  38.8% 
Male      13  72.2%      10  58.8%      12  70.6%      6  40.0%      41  61.2% 
Race/Ethnicity, Customized 
[Units: Participants]
         
Hispanic   1   0   0   3   4 
Non-Hispanic   17   17   17   12   63 
Race/Ethnicity, Customized 
[Units: Participants]
         
Asian   1   1   2   0   4 
Black or African American   4   0   0   1   5 
White   13   14   13   12   52 
Multi-Racial   0   1   2   2   5 
Other   0   1   0   0   1 
Region of Enrollment 
[Units: Participants]
         
United States   18   17   17   15   67 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 78.77  (20.349)   81.19  (15.673)   76.72  (13.672)   73.73  (8.939)   77.73  (15.354) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 174.47  (8.934)   177.58  (9.891)   179.77  (8.833)   169.13  (10.593)   175.41  (10.114) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.89  (6.458)   25.73  (4.516)   23.66  (3.406)   25.93  (3.743)   25.29  (4.733) 
Seropositivity Status at Baseline 
[Units: Participants]
         
Seropositive   1   4   1   2   8 
Seronegative   17   13   16   13   59 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff   [ Time Frame: 28 Days after each dose ]

2.  Primary:   Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity   [ Time Frame: 28 Days after each dose ]

3.  Primary:   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   [ Time Frame: 14 days after each dose ]

4.  Primary:   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   [ Time Frame: 14 days after each dose ]

5.  Primary:   Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity   [ Time Frame: 28 Days after each dose ]

6.  Primary:   Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)   [ Time Frame: 118 Days ]

7.  Primary:   Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection   [ Time Frame: Day 28 ]

8.  Primary:   Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection   [ Time Frame: Day 118 ]

9.  Primary:   Percentage of Participants With Unsolicited Vaccine-Related SAEs   [ Time Frame: Dose 1 until 28 days after Dose 2 (Up to Day 118) ]

10.  Secondary:   Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes   [ Time Frame: Days 0, 28, 90, 118 and 270 ]

11.  Secondary:   Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270   [ Time Frame: Days 90 and 270 ]

12.  Secondary:   Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination   [ Time Frame: Day 0 to Day 104 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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 cannot require changes to the communication and cannot extend the embargo.
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Clinical Science
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01765426     History of Changes
Other Study ID Numbers: 11-0049
U1111-1178-6503 ( Registry Identifier: WHO )
First Submitted: December 17, 2012
First Posted: January 10, 2013
Results First Submitted: November 4, 2016
Results First Posted: January 5, 2017
Last Update Posted: August 8, 2017