NCT01765426 is a Phase 1 clinical trial of TDV in Healthy Volunteers, sponsored by Takeda.

Who is sponsoring NCT01765426?

NCT01765426 is sponsored by Takeda.

What drugs are being tested in NCT01765426?

Interventions in NCT01765426: TDV, Placebo.

What condition does NCT01765426 study?

NCT01765426 studies Healthy Volunteers.

Is NCT01765426 still recruiting?

NCT01765426 is currently completed. Last updated 18 July 2019.

Are results published for NCT01765426?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-07-18 · How we verify

NCT01765426

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 18 July 2019

What this trial tests

Phase 1 trial testing TDV in Healthy Volunteers in 67 participants. Completed in 26 June 2014.

Timeline

15 February 2013

Primary endpoint
26 June 2014

26 June 2014

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	67
Start date	15 February 2013
Primary completion	26 June 2014
Estimated completion	26 June 2014
Sites	2 locations across United States

Drugs / interventions tested

TDV — full drug profile →
Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff Primary · 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 (sever

Edema, Grade 0 (None)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	16.7
Group 2: TDV Using PharmaJet® Injector	11.8
Group 3: TDV Using Needle and Syringe	11.8
Group 4: TDV Using PharmaJet® Injector	13.3

Edema, Any Severity >Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	83.3
Group 2: TDV Using PharmaJet® Injector	88.2
Group 3: TDV Using Needle and Syringe	88.2
Group 4: TDV Using PharmaJet® Injector	86.7

Edema, Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	77.8
Group 2: TDV Using PharmaJet® Injector	82.4
Group 3: TDV Using Needle and Syringe	76.5
Group 4: TDV Using PharmaJet® Injector	66.7

Edema, Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	5.9
Group 3: TDV Using Needle and Syringe	11.8
Group 4: TDV Using PharmaJet® Injector	20.0

Erythema, Grade 0 (None)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	11.1
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	6.7

Erythema, Any Severity >Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	88.9
Group 2: TDV Using PharmaJet® Injector	100.0
Group 3: TDV Using Needle and Syringe	100.0
Group 4: TDV Using PharmaJet® Injector	93.3

Erythema, Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	55.6
Group 2: TDV Using PharmaJet® Injector	23.5
Group 3: TDV Using Needle and Syringe	29.4
Group 4: TDV Using PharmaJet® Injector	20.0

Erythema, Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	33.3
Group 2: TDV Using PharmaJet® Injector	70.6
Group 3: TDV Using Needle and Syringe	64.7
Group 4: TDV Using PharmaJet® Injector	60.0

Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity Primary · 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.

Any Severity

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	83.3
Group 2: TDV Using PharmaJet® Injector	76.5
Group 3: TDV Using Needle and Syringe	88.2
Group 4: TDV Using PharmaJet® Injector	80.0

Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	22.2
Group 2: TDV Using PharmaJet® Injector	35.3
Group 3: TDV Using Needle and Syringe	52.9
Group 4: TDV Using PharmaJet® Injector	53.3

Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	44.4
Group 2: TDV Using PharmaJet® Injector	23.5
Group 3: TDV Using Needle and Syringe	17.6
Group 4: TDV Using PharmaJet® Injector	20.0

Grade 3 (Severe)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	11.1
Group 2: TDV Using PharmaJet® Injector	17.6
Group 3: TDV Using Needle and Syringe	5.9
Group 4: TDV Using PharmaJet® Injector	6.7

Grade 4 (Life Threatening)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	11.8
Group 4: TDV Using PharmaJet® Injector	0

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 Primary · 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 reac

Temperature, Grade 0 (None)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	94.4
Group 2: TDV Using PharmaJet® Injector	100.0
Group 3: TDV Using Needle and Syringe	88.2
Group 4: TDV Using PharmaJet® Injector	100.0

Temperature, Any Severity >Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	11.8
Group 4: TDV Using PharmaJet® Injector	0

Temperature, Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	5.9
Group 4: TDV Using PharmaJet® Injector	0

Temperature, Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	0
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	5.9
Group 4: TDV Using PharmaJet® Injector	0

Headache, Grade 0 (None)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	61.1
Group 2: TDV Using PharmaJet® Injector	29.4
Group 3: TDV Using Needle and Syringe	41.2
Group 4: TDV Using PharmaJet® Injector	46.7

Headache, Any Severity >Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	38.9
Group 2: TDV Using PharmaJet® Injector	70.6
Group 3: TDV Using Needle and Syringe	58.8
Group 4: TDV Using PharmaJet® Injector	53.3

Headache, Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	22.2
Group 2: TDV Using PharmaJet® Injector	58.8
Group 3: TDV Using Needle and Syringe	58.8
Group 4: TDV Using PharmaJet® Injector	46.7

Headache, Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	16.7
Group 2: TDV Using PharmaJet® Injector	11.8
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	6.7

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 Primary · 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.

Swelling, Grade 0 (None)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	50.0
Group 2: TDV Using PharmaJet® Injector	41.2
Group 3: TDV Using Needle and Syringe	35.3
Group 4: TDV Using PharmaJet® Injector	40.0

Swelling, Any Severity >Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	50.0
Group 2: TDV Using PharmaJet® Injector	58.8
Group 3: TDV Using Needle and Syringe	64.7
Group 4: TDV Using PharmaJet® Injector	60.0

Swelling, Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	44.4
Group 2: TDV Using PharmaJet® Injector	47.1
Group 3: TDV Using Needle and Syringe	47.1
Group 4: TDV Using PharmaJet® Injector	40.0

Swelling, Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	11.8
Group 3: TDV Using Needle and Syringe	17.6
Group 4: TDV Using PharmaJet® Injector	20.0

Redness, Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	22.2
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	20.0

Redness, Any Severity >Grade 0

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	77.8
Group 2: TDV Using PharmaJet® Injector	100
Group 3: TDV Using Needle and Syringe	100.0
Group 4: TDV Using PharmaJet® Injector	80.0

Redness, Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	44.4
Group 2: TDV Using PharmaJet® Injector	29.4
Group 3: TDV Using Needle and Syringe	23.5
Group 4: TDV Using PharmaJet® Injector	13.3

Redness, Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	33.3
Group 2: TDV Using PharmaJet® Injector	64.7
Group 3: TDV Using Needle and Syringe	64.7
Group 4: TDV Using PharmaJet® Injector	46.7

Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity Primary · 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.

Any Severity

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	16.7
Group 2: TDV Using PharmaJet® Injector	17.6
Group 3: TDV Using Needle and Syringe	52.9
Group 4: TDV Using PharmaJet® Injector	33.3

Grade 1 (Mild)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	11.1
Group 2: TDV Using PharmaJet® Injector	11.8
Group 3: TDV Using Needle and Syringe	41.2
Group 4: TDV Using PharmaJet® Injector	33.3

Grade 2 (Moderate)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	11.8
Group 4: TDV Using PharmaJet® Injector	0

Grade 3 (Severe)

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	0
Group 2: TDV Using PharmaJet® Injector	5.9
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) Primary · 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.

Alanine aminotransferase increased

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

Aspartate aminotransferase increased

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	5.9
Group 4: TDV Using PharmaJet® Injector	0

Blood bilirubin increased

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

Blood creatine phosphokinase increased

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	11.8
Group 3: TDV Using Needle and Syringe	11.8
Group 4: TDV Using PharmaJet® Injector	0

Occult blood

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	0
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	5.9
Group 4: TDV Using PharmaJet® Injector	0

Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection Primary · 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.

DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	75.0	47.6 – 92.7
Group 2: TDV Using PharmaJet® Injector	38.5	13.9 – 68.4
Group 3: TDV Using Needle and Syringe	62.5	35.4 – 84.8
Group 4: TDV Using PharmaJet® Injector	84.6	54.6 – 98.1

DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	62.5	35.4 – 84.8
Group 2: TDV Using PharmaJet® Injector	61.5	31.6 – 86.1
Group 3: TDV Using Needle and Syringe	50.0	24.7 – 75.3
Group 4: TDV Using PharmaJet® Injector	76.9	46.2 – 95.0

DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	56.3	29.9 – 80.2
Group 2: TDV Using PharmaJet® Injector	23.1	5.0 – 53.8
Group 3: TDV Using Needle and Syringe	31.3	11.0 – 58.7
Group 4: TDV Using PharmaJet® Injector	46.2	19.2 – 74.9

DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	31.3	11.0 – 58.7
Group 2: TDV Using PharmaJet® Injector	23.1	5.0 – 53.8
Group 3: TDV Using Needle and Syringe	50.0	24.7 – 75.3
Group 4: TDV Using PharmaJet® Injector	38.5	13.9 – 68.4

Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection Primary · 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.

DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	75.0	47.6 – 92.7
Group 2: TDV Using PharmaJet® Injector	69.2	38.6 – 90.9
Group 3: TDV Using Needle and Syringe	87.5	61.7 – 98.4
Group 4: TDV Using PharmaJet® Injector	84.6	54.6 – 98.1

DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	68.8	41.3 – 89.0
Group 2: TDV Using PharmaJet® Injector	69.2	38.6 – 90.9
Group 3: TDV Using Needle and Syringe	62.5	35.4 – 84.8
Group 4: TDV Using PharmaJet® Injector	84.6	54.6 – 98.1

DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	75.0	47.6 – 92.7
Group 2: TDV Using PharmaJet® Injector	69.2	38.6 – 90.9
Group 3: TDV Using Needle and Syringe	87.5	61.7 – 98.4
Group 4: TDV Using PharmaJet® Injector	84.6	54.6 – 98.1

DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	31.3	11.0 – 58.7
Group 2: TDV Using PharmaJet® Injector	30.8	9.1 – 61.4
Group 3: TDV Using Needle and Syringe	81.3	54.4 – 96.0
Group 4: TDV Using PharmaJet® Injector	53.8	25.1 – 80.8

Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes Secondary · Days 0, 28, 90, 118 and 270

Day 0 DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 2: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 3: TDV Using Needle and Syringe	5.0	5.0 – 5.0
Group 4: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0

Day 0 DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 2: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 3: TDV Using Needle and Syringe	5.0	5.0 – 5.0
Group 4: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0

Day 0 DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 2: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 3: TDV Using Needle and Syringe	5.0	5.0 – 5.0
Group 4: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0

Day 0 DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 2: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0
Group 3: TDV Using Needle and Syringe	5.0	5.0 – 5.0
Group 4: TDV Using PharmaJet® Injector	5.0	5.0 – 5.0

Day 28 DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	28.3	13.0 – 61.3
Group 2: TDV Using PharmaJet® Injector	10.5	4.5 – 24.9
Group 3: TDV Using Needle and Syringe	27.1	12.5 – 58.7
Group 4: TDV Using PharmaJet® Injector	29.0	12.3 – 68.6

Day 28 DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	293.4	48.0 – 1792.9
Group 2: TDV Using PharmaJet® Injector	311.6	41.8 – 2320.7
Group 3: TDV Using Needle and Syringe	146.7	24.0 – 896.5
Group 4: TDV Using PharmaJet® Injector	1006.9	135.2 – 7499.7

Day 28 DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	32.2	13.2 – 78.7
Group 2: TDV Using PharmaJet® Injector	11.1	4.1 – 30.0
Group 3: TDV Using Needle and Syringe	10.0	4.1 – 24.4
Group 4: TDV Using PharmaJet® Injector	19.0	7.0 – 51.1

Day 28 DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	13.5	5.0 – 36.4
Group 2: TDV Using PharmaJet® Injector	11.7	3.9 – 35.2
Group 3: TDV Using Needle and Syringe	32.2	12.0 – 86.7
Group 4: TDV Using PharmaJet® Injector	20.0	6.7 – 60.0

Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 Secondary · 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.

Day 90 DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	68.8	41.3 – 89.0
Group 2: TDV Using PharmaJet® Injector	61.5	31.6 – 86.1
Group 3: TDV Using Needle and Syringe	62.5	35.4 – 84.8
Group 4: TDV Using PharmaJet® Injector	76.9	46.2 – 95.0

Day 90 DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	75.0	47.6 – 92.7
Group 2: TDV Using PharmaJet® Injector	69.2	38.6 – 90.9
Group 3: TDV Using Needle and Syringe	43.8	19.8 – 70.1
Group 4: TDV Using PharmaJet® Injector	84.6	54.6 – 98.1

Day 90 DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	62.5	35.4 – 84.8
Group 2: TDV Using PharmaJet® Injector	61.5	31.6 – 86.1
Group 3: TDV Using Needle and Syringe	43.8	19.8 – 70.1
Group 4: TDV Using PharmaJet® Injector	61.5	31.6 – 86.1

Day 90 DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	18.8	4.0 – 45.6
Group 2: TDV Using PharmaJet® Injector	30.8	9.1 – 61.4
Group 3: TDV Using Needle and Syringe	56.3	29.9 – 80.2
Group 4: TDV Using PharmaJet® Injector	46.2	19.2 – 74.9

Day 270 DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	62.5	35.4 – 84.8
Group 2: TDV Using PharmaJet® Injector	46.2	19.2 – 74.9
Group 3: TDV Using Needle and Syringe	75.0	47.6 – 92.7
Group 4: TDV Using PharmaJet® Injector	61.5	31.6 – 86.1

Day 270 DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	62.5	35.4 – 84.8
Group 2: TDV Using PharmaJet® Injector	69.2	38.6 – 90.9
Group 3: TDV Using Needle and Syringe	50.0	24.7 – 75.3
Group 4: TDV Using PharmaJet® Injector	84.6	54.6 – 98.1

Day 270 DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	68.8	41.3 – 89.0
Group 2: TDV Using PharmaJet® Injector	53.8	25.1 – 80.8
Group 3: TDV Using Needle and Syringe	75.0	47.6 – 92.7
Group 4: TDV Using PharmaJet® Injector	69.2	38.6 – 90.9

Day 270 DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	25.0	7.3 – 52.4
Group 2: TDV Using PharmaJet® Injector	23.1	5.0 – 53.8
Group 3: TDV Using Needle and Syringe	75.0	47.6 – 92.7
Group 4: TDV Using PharmaJet® Injector	46.2	19.2 – 74.9

Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination Secondary · 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.

DEN-1

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	0
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

DEN-2

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	38.9
Group 2: TDV Using PharmaJet® Injector	23.5
Group 3: TDV Using Needle and Syringe	23.5
Group 4: TDV Using PharmaJet® Injector	53.3

DEN-3

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	5.6
Group 2: TDV Using PharmaJet® Injector	5.9
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

DEN-4

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	0
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

Percentage of Participants With Unsolicited Vaccine-Related SAEs Primary · 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.

Group	Value	95% CI
Group 1: TDV Using PharmaJet® Injector	0
Group 2: TDV Using PharmaJet® Injector	0
Group 3: TDV Using Needle and Syringe	0
Group 4: TDV Using PharmaJet® Injector	0

Adverse events — posted to ClinicalTrials.gov

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).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group 1: TDV Using PharmaJet® Injector

Serious: 0/18 (0%)

Deaths: —

Group 2: TDV Using PharmaJet® Injector

Serious: 0/17 (0%)

Deaths: —

Group 3: TDV Using Needle and Syringe

Serious: 0/17 (0%)

Deaths: —

Group 4: TDV Using PharmaJet® Injector

Serious: 0/15 (0%)

Deaths: —

Other adverse events (85 terms — click to expand)

Reaction	System	Group 1: TDV Using PharmaJ…	Group 2: TDV Using PharmaJ…	Group 3: TDV Using Needle …	Group 4: TDV Using PharmaJ…
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Injection site haematoma	General disorders	—	—	—	—
Injection site warmth	General disorders	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Vessel puncture site haematoma	General disorders	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Excoriation	Injury, poisoning and procedural complications	—	—	—	—
Laceration	Injury, poisoning and procedural complications	—	—	—	—
Muscle strain	Injury, poisoning and procedural complications	—	—	—	—
Sunburn	Injury, poisoning and procedural complications	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Aphthous stomatitis	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Gastrointestinal disorder	Gastrointestinal disorders	—	—	—	—
Gingival pain	Gastrointestinal disorders	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Chest pain	General disorders	—	—	—	—
Chills	General disorders	—	—	—	—
Feeling abnormal	General disorders	—	—	—	—
Influenza like illness	General disorders	—	—	—	—
Injection site discolouration	General disorders	—	—	—	—
Injection site haemorrhage	General disorders	—	—	—	—

Data from ClinicalTrials.gov NCT01765426 adverse events section.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Alternative Methods of Vaccine Delivery: An Overview of Edible and Intradermal Vaccines.
Criscuolo E, Caputo V, Diotti RA, Sautto GA, et al · · 2019 · cited 66× · PMID 30949518 · DOI 10.1155/2019/8303648
Dengue vaccines: recent developments, ongoing challenges and current candidates.
McArthur MA, Sztein MB, Edelman R. · · 2013 · cited 66× · PMID 23984962 · DOI 10.1586/14760584.2013.815412
A phase 1 study of safety and immunogenicity following intradermal administration of a tetravalent dengue vaccine candidate.
Jackson LA, Rupp R, Papadimitriou A, Wallace D, et al · · 2018 · cited 34× · PMID 29789238 · DOI 10.1016/j.vaccine.2018.05.028

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01765426 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 18 July 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01765426.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01765426

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of TDV

Other recruiting trials for Healthy Volunteers

Other Takeda trials

Verify against primary sources