HealthyPhase 1NCT01542632

A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

A Phase 1 study testing Takeda's Tetravalent Dengue Vaccine Candidate (TDV) and TDV New Formulation in people with Healthy, run by Takeda at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) and TDV New Formulation
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 140 participants
Where: 3 sitesUnited States
Study dates: 1 Feb 2012to 10 Jan 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female at least 18 years and ≤ 45 years old at time of screening
In good health as determined by medical history, physical examination including height and weight
Normal clinical safety laboratory examinations [Sodium (Na), Potassium (K), Glucose, Blood Urea Nitrogen (BUN), creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, White Blood Cell (WBC), neutrophil count, hemoglobin, platelets, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and urinalysis (by dipstick)].
Weight: Body Mass Index (BMI) ≤32
Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and Hepatitis B surface antigen

Who cannot join

Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator
Clinically significant ECG findings
History of any significant dermatologic disease in the last 6 months,
History of diabetes mellitus
History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines
Hypersensitivity to any vaccine

Show all 18Show fewer

Receipt of any vaccine in the 4 weeks preceding the first vaccination
Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study
Known history of Japanese Encephalitis Virus (JEV) and/or Yellow Fever (YF)
Previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, yellow fever (YF) and Japanese Encephalitis (JE)
Seropositivity to dengue or West Nile (WN) virus
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months
Use within the previous 6 months of systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or within the last 3 months. Note, inhaled prednisone (or equivalent) is allowed
Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination
Use of any prescription or over the counter medications (besides those specifically mentioned above or those required for medical management of concurrent diseases) 7 days before the first vaccination (Day 0)
Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
Donation of blood 6 weeks before the first dose(s) (Day 0) until 30 days after the dose on day 90
Females who are pregnant or lactating

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Heart Center of the Rockies
Fort Collins, Colorado, 80528
University of Texas Medical Branch
Galveston, Texas, 77555
Advanced Clinical Research
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Randomized, Phase 1b Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers Between the Ages of 18 - 45 Years

Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline [during the screening period or on day of vaccination (Day 0)], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline [during the screening period or on day of vaccination (Day 0)], then on Days 30, 90 and 120.

The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).

Conditions: Healthy
Being tested: Takeda's Tetravalent Dengue Vaccine Candidate (TDV), TDV New Formulation, Placebo, New Formulation Placebo
Keywords: safety and immunogenicity of dengue vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)Biological
TDV subcutaneous injection
TDV New FormulationBiological
TDV New Formulation subcutaneous injection
PlaceboDrug
Placebo subcutaneous injection
New Formulation PlaceboDrug
New Formulation placebo subcutaneous injection

Study groups in NCT01542632
Study group	Role	What they receive
Group 1	Experimental	Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and placebo, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. Receives: Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Drug: Placebo
Group 2	Experimental	TDV, 0.5 mL, subcutaneous injection in one arm and TDV 0.5 mL, subcutaneous injection in the other arm on Day 0. Placebo, 0.5 mL, subcutaneous injection on Day 90. Receives: Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV); Drug: Placebo
Group 3	Experimental	TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. Receives: Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)
Group 4	Experimental	TDV new formulation, 0.5 mL, subcutaneous injection in one arm and new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. Receives: Biological: TDV New Formulation; Drug: New Formulation Placebo
Group 5	Experimental	TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. Receives: Biological: TDV New Formulation; Drug: New Formulation Placebo
Group 6	Experimental	1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90. Receives: Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported
Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.
Measured: Day 0 to Day 104
Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Measured: For 30 days after each dose (Up to Day 120)
Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.
Measured: For 30 days after each dose (Up to Day 120)
Rate of Seroconversion to Each of Four Dengue Serotypes
Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
Measured: Up to 30 days after the last immunization (Up to Day 120)

Secondary outcomes (2)

Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations
Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.
Measured: various timepoints up to 30 days after each dose (Up to Day 120)
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Measured: Days 30, 90 and 120 after 1st vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201210 Jan 2014

First posted2 Mar 2012 (estimated)
Study start1 Feb 2012
Primary completion1 Jan 2014
Study completion10 Jan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 140 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01542632
Sponsor's protocol ID: INV-DEN-104
Other IDs: U1111-1177-8166
Status last verified: Jul 2019
First submitted: 27 Feb 2012
Last updated: 18 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Phase 1b Study to Investigate the Safety and Immunogenicity of Various Schedules of Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers Between the Ages of 18 - 45 Years
ClinicalTrials.gov ID: NCT01542632
Acronym / sponsor ID: INV-DEN-104
Conditions: Healthy
Keywords: safety and immunogenicity of dengue vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 140 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 1 Feb 2012 (actual)
Primary completion: 1 Jan 2014 (actual)
Study completion: 10 Jan 2014 (actual)
First posted: 2 Mar 2012 (estimated)
Results: Posted 9 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group 1	Experimental	Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV), Drug: PlaceboTakeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and placebo, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
Group 2	Experimental	Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV), Drug: PlaceboTDV, 0.5 mL, subcutaneous injection in one arm and TDV 0.5 mL, subcutaneous injection in the other arm on Day 0. Placebo, 0.5 mL, subcutaneous injection on Day 90.
Group 3	Experimental	Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
Group 4	Experimental	Biological: TDV New Formulation, Drug: New Formulation PlaceboTDV new formulation, 0.5 mL, subcutaneous injection in one arm and new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
Group 5	Experimental	Biological: TDV New Formulation, Drug: New Formulation PlaceboTDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
Group 6	Experimental	Biological: Takeda's Tetravalent Dengue Vaccine Candidate (TDV)1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female at least 18 years and ≤ 45 years old at time of screening
In good health as determined by medical history, physical examination including height and weight
Normal clinical safety laboratory examinations [Sodium (Na), Potassium (K), Glucose, Blood Urea Nitrogen (BUN), creatinine, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), total bilirubin, White Blood Cell (WBC), neutrophil count, hemoglobin, platelets, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), and urinalysis (by dipstick)].
Weight: Body Mass Index (BMI) ≤32
Blood tests negative for antibodies to Human Immuno-virus (HIV-1), Hepatitis C, and Hepatitis B surface antigen

Key exclusion criteria (18 listed)

Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator
Clinically significant ECG findings
History of any significant dermatologic disease in the last 6 months,
History of diabetes mellitus
History of recurring headaches or migraines (more frequent than once per week) or on prescription medication for treatment of recurring headaches or migraines

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Takeda's Tetravalent Dengue Vaccine Candidate (TDV)TDV subcutaneous injection	Biological	Group 1, Group 2, Group 3, Group 6
TDV New FormulationTDV New Formulation subcutaneous injection	Biological	Group 4, Group 5
PlaceboPlacebo subcutaneous injection	Drug	Group 1, Group 2
New Formulation PlaceboNew Formulation placebo subcutaneous injection	Drug	Group 4, Group 5

Primary outcome

Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported
Time frame: Day 0 to Day 104
Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.
Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose
Time frame: For 30 days after each dose (Up to Day 120)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose
Time frame: For 30 days after each dose (Up to Day 120)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.
Rate of Seroconversion to Each of Four Dengue Serotypes
Time frame: Up to 30 days after the last immunization (Up to Day 120)
Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.

2 secondary outcomes

Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations
Time frame: various timepoints up to 30 days after each dose (Up to Day 120)
Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Time frame: Days 30, 90 and 120 after 1st vaccination

Results and safety

Results posted to the registry on 9 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (D0:TDV,P D90:TDV)	25	25
Group 2 (D0:TDV,TDV D90:P)	25	24
Group 3 (D0:TDV,TDV D90:TDV)	24	23
Group 4 (D0:TDVN,P D90:TDVN,P)	21	19
Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)	21	17
Group 6 (D0:1/10TDV D90:1/10TDV)	24	24

Primary outcome: Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported

Time frame: Day 0 to Day 104. Number. Unit: participants

Measure	Group 1 (D0:TDV,P D90:TDV) n = 25	Group 2 (D0:TDV,TDV D90:P) n = 25	Group 3 (D0:TDV,TDV D90:TDV) n = 24	Group 4 (D0:TDVN,P D90:TDVN,P) n = 21	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n = 21	Group 6 (D0:1/10TDV D90:1/10TDV) n = 24
Edema=0	25	25	24	21	21	24
Erythema=0	25	25	24	21	21	24
Itching=0	24	19	23	20	21	22
Itching=1	1	6	1	1	0	2
Pain=0	19	18	19	16	18	20
Pain=1	6	7	4	5	2	4
Pain=2	0	0	1	0	1	0

Population analysed: Safety population included all enrolled participants who received at least one dose of study drug.

Primary outcome: Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose

Time frame: For 30 days after each dose (Up to Day 120). Number. Unit: participants

Measure	Group 1 (D0:TDV,P D90:TDV) n = 25	Group 2 (D0:TDV,TDV D90:P) n = 25	Group 3 (D0:TDV,TDV D90:TDV) n = 24	Group 4 (D0:TDVN,P D90:TDVN,P) n = 21	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n = 21	Group 6 (D0:1/10TDV D90:1/10TDV) n = 24
Value	22	19	21	17	17	18

Population analysed: Safety Population included all enrolled participants who received at least one dose of study drug.

Primary outcome: Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose

Time frame: For 30 days after each dose (Up to Day 120). Number. Unit: participants

Measure	Group 1 (D0:TDV,P D90:TDV) n = 25	Group 2 (D0:TDV,TDV D90:P) n = 25	Group 3 (D0:TDV,TDV D90:TDV) n = 24	Group 4 (D0:TDVN,P D90:TDVN,P) n = 21	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n = 21	Group 6 (D0:1/10TDV D90:1/10TDV) n = 24
Value	20	16	18	14	12	14

Population analysed: Safety Population included all enrolled participants who received at least one dose of study drug.

Primary outcome: Rate of Seroconversion to Each of Four Dengue Serotypes

Time frame: Up to 30 days after the last immunization (Up to Day 120). Number. Unit: percentage of participants

Measure	Group 1 (D0:TDV,P D90:TDV) n = 25	Group 2 (D0:TDV,TDV D90:P) n = 25	Group 3 (D0:TDV,TDV D90:TDV) n = 24	Group 4 (D0:TDVN,P D90:TDVN,P) n = 21	Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN) n = 19	Group 6 (D0:1/10TDV D90:1/10TDV n = 24
Dengue-1 Day 30 (n=25, 24, 24, 21, 19, 24)	100.0	95.8	100.0	81.0	89.5	100.0
Dengue-2 Day 30 (n=25, 24, 24, 21, 19, 24)	96.0	100.0	100.0	100.0	100.0	95.8
Dengue-3 Day 30 (n=25, 24, 24, 21, 19, 24)	84.0	100.0	87.5	85.7	94.7	66.7
Dengue-4 Day 30 (n=25, 24, 24, 21, 19, 24)	36.0	58.3	33.3	81.0	57.9	29.2
Dengue-1 Day 90 (n=25, 24, 23, 20, 18, 24)	96.0	91.7	95.7	75.0	72.2	87.5
Dengue-2 Day 90 (n=25, 24, 23, 20, 18, 24)	100.0	100.0	100.0	100.0	100.0	91.7
Dengue-3 Day 90 (n=25, 24, 23, 20, 18, 24)	80.0	91.7	82.6	75.0	83.3	62.5
Dengue-4 Day 90 (n=25, 24, 23, 20, 18, 24)	24.0	29.2	21.7	50.0	38.9	37.5

Population analysed: Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 to Day 120. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 (D0:TDV,P D90:TDV)	0 of 25 (0%)	24 of 25 (96%)	Not reported
Group 2 (D0:TDV,TDV D90:P)	0 of 25 (0%)	18 of 25 (72%)	Not reported
Group 3 (D0:TDV,TDV D90:TDV)	0 of 24 (0%)	20 of 24 (83.3%)	Not reported
Group 4 (D0:TDVN,P D90:TDVN,P)	0 of 21 (0%)	16 of 21 (76.2%)	Not reported
Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)	0 of 21 (0%)	17 of 21 (81%)	Not reported
Group 6 (D0:1/10TDV D90:1/10TDV)	0 of 24 (0%)	18 of 24 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilad Gordon, MD study director

Inviragen Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Takeda's Tetravalent Dengue Vaccine Candidate (TDV) and TDV New Formulation in people with Healthy, run by Takeda at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported (time frame: Day 0 to Day 104). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01542632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.