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Trial record 59 of 97 for:    "Dengue Hemorrhagic Fever"

Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity

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.
ClinicalTrials.gov Identifier: NCT01728792
Recruitment Status : Completed
First Posted : November 20, 2012
Results First Posted : January 4, 2017
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Dengue Fever
Intervention Biological: TDV
Enrollment 80
Recruitment Details Participants took part in the study at 1 investigative site in the United States from 22 January 2013 to 21 November 2013.
Pre-assignment Details Healthy participants were randomized equally to 1 of 5 TDV treatment groups: 2 doses subcutaneous (SC) on Day 0 using needle/syringe, 2 doses intramuscular (IM) on Day 0 using needle/syringe, 1 dose IM on Days 0 and 90 using needle/syringe, 2 doses SC on Day 0 using the PharmaJet Stratis™ device and 2 doses IM on Day 0 using the PharmaJet Stratis™.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe. TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe. TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe. TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device. TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Period Title: Overall Study
Started 14 16 17 17 16
Completed 11 14 13 14 16
Not Completed 3 2 4 3 0
Reason Not Completed
Withdrawal of Consent             1             1             0             1             0
Lost to Follow-up             2             1             4             2             0
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0 Total
Hide Arm/Group Description Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe. TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe. TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe. TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device. TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device. Total of all reporting groups
Overall Number of Baseline Participants 14 16 17 17 16 80
Hide Baseline Analysis Population Description
Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom any post-vaccination safety data has been obtained.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 16 participants 17 participants 17 participants 16 participants 80 participants
28.2  (5.81) 30.2  (7.49) 27.5  (7.92) 30.4  (7.48) 30.8  (7.79) 29.4  (7.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 17 participants 17 participants 16 participants 80 participants
Female
5
  35.7%
6
  37.5%
7
  41.2%
6
  35.3%
6
  37.5%
30
  37.5%
Male
9
  64.3%
10
  62.5%
10
  58.8%
11
  64.7%
10
  62.5%
50
  62.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 17 participants 17 participants 16 participants 80 participants
Hispanic 0 1 2 1 0 4
Non-Hispanic 14 15 15 16 16 76
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 17 participants 17 participants 16 participants 80 participants
American Indian or Alaska Native 0 0 1 0 2 3
Asian 1 0 1 0 0 2
Black or African American 1 2 2 4 1 10
Native Hawaiian or Pacific Islander 1 0 0 0 0 1
White 11 14 12 13 13 63
Missing 0 0 1 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 16 participants 17 participants 17 participants 16 participants 80 participants
14 16 17 17 16 80
1.Primary Outcome
Title Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
Hide Description Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number 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. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Time Frame For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 14 16 17 17 16
Measure Type: Number
Unit of Measure: participants
Erythema_Any Grade 2 0 0 4 3
Erythema_Grade 1 1 0 0 3 3
Erythema_Grade 2 1 0 0 1 0
Edema_Any Grade 0 0 0 0 0
Pain_Any Grade 1 5 7 6 7
Pain_Grade 1 1 5 6 5 7
Pain_Grade 2 0 0 1 1 0
Itching_Any Grade 1 0 0 2 2
Itching_Grade 1 1 0 0 0 1
Itching_Grade 2 0 0 0 2 1
2.Primary Outcome
Title Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
Hide Description Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant’s worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
Time Frame For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 14 16 17 17 16
Measure Type: Number
Unit of Measure: participants
Erythema_Any Grade (n=9,10,14,14,13) 3 0 0 4 3
Erythema_Grade 1 (n=9,10,14,14,13) 2 0 0 2 2
Erythema_Grade 2 (n=9,10,14,14,13) 1 0 0 1 1
Erythema_Grade 3 (n=9,10,14,14,13) 0 0 0 1 0
Edema_Any Grade (n=8,10,14,12,12) 2 0 0 2 2
Edema_Grade 1 (n=8,10,14,12,12) 2 0 0 1 2
Edema_Grade 2 (n=8,10,14,12,12) 0 0 0 1 0
Pain_Any Grade (n=13,16,17,17,16) 10 7 8 11 10
Pain_Grade 1 (n=13,16,17,17,16) 7 7 8 9 7
Pain_Grade 2 (n=13,16,17,17,16) 3 0 0 2 3
Itching_Any Grade (n=13,15,17,17,16) 0 0 0 3 2
Itching_Grade 1 (n=13,15,17,17,16) 0 0 0 2 2
Itching_Grade 2 (n=13,15,17,17,16) 0 0 0 1 0
3.Primary Outcome
Title Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
Hide Description Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.
Time Frame For 14 days after each vaccination (Up to Day 14 and/or Day 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 14 16 17 17 16
Measure Type: Number
Unit of Measure: participants
Fever_Any Grade (n=13,16,17,17,16) 0 0 0 0 0
Headache_Any Grade 3 3 9 6 5
Headache_Grade 1 3 2 3 5 3
Headache_Grade 2 0 0 5 0 2
Headache_Grade 3 0 1 1 1 0
Myalgia_Any Grade 2 2 3 3 2
Myalgia_Grade 1 2 2 1 3 2
Myalgia_Grade 2 0 0 2 0 0
Arthralgia_Any Grade 2 0 1 1 3
Arthralgia_Grade 1 2 0 0 1 3
Arthralgia_Grade 2 0 0 1 0 0
Eye Pain_Any Grade 0 0 0 0 0
Photophobia_Any Grade 2 1 4 0 2
Photophobia_Grade 1 2 0 3 0 1
Photophobia_Grade 2 0 1 1 0 1
Fatigue_Any Grade 6 5 6 6 2
Fatigue_Grade 1 3 4 1 6 1
Fatigue_Grade 2 3 1 5 0 0
Fatigue_Grade 3 0 0 0 0 1
Rash_Any Grade 1 0 3 3 1
Rash_Grade 1 1 0 3 2 0
Rash_Grade 2 0 0 0 1 1
Nausea_Any Grade 3 3 4 2 3
Nausea_Grade1 2 2 2 1 3
Nausea_Grade 2 1 1 2 0 0
Nausea_Grade 3 0 0 0 1 0
Vomiting_Any Grade 0 0 0 0 0
4.Primary Outcome
Title Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose
Hide Description 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. The investigator assessed whether the AE was related to the study vaccination.
Time Frame For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 14 16 17 17 16
Measure Type: Number
Unit of Measure: participants
1 2 2 3 3
5.Primary Outcome
Title Number of Participants With at Least 1 Serious Adverse Event During the Study
Hide Description

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.

A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

Time Frame First Vaccination to End of Study (Up to Day 120)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 14 16 17 17 16
Measure Type: Number
Unit of Measure: participants
0 0 0 0 1
6.Primary Outcome
Title Seroconversion Rate to Each of Four Dengue Serotypes
Hide Description Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
Time Frame Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol deviations results in testing not performed for outcome measure.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
Hide Description Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. "n" in each of the categories is the number of participants with data available.
Time Frame Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 14 16 17 17 16
Measure Type: Number
Unit of Measure: participants
Day 0_TDV-1, TDV-2, TDV-3, TDV-4 0 0 0 0 0
Day 7_TDV-1, TDV-2, TDV-3, TDV-4 (n=7,8,9,8,7) 0 0 0 0 0
Day 9_TDV-1, TDV-3, TDV-4 (n=6,8,7,9,9) 0 0 0 0 0
Day 9 _TDV-2 (n=6,8,7,9,9) 3 2 1 5 3
Day 11_TDV-1, TDV-3 (n=7,8,9,7,7) 0 0 0 0 0
Day 11_TDV-2 (n=7,8,9,7,7) 3 5 4 3 3
Day 11_TDV-4 (n=7,8,9,7,7) 0 0 1 0 0
Day 14_TDV-1, TDV-3, TDV-4 (n=6,8,7,10,9) 0 0 0 0 0
Day 14_TDV-2 (n=6,8,7,10,9) 2 3 1 9 3
Day 17_TDV-1, TDV-3, TDV-4 (n=7,8,9,8,7) 0 0 0 0 0
Day 17_TDV-2 (n=7,8,9,8,7) 4 2 2 3 2
Day 21_TDV-1, TDV-3, TDV-4 (n=6,8,8,9,9) 0 0 0 0 0
Day 21_TDV-2 (n=6,8,8,9,9) 1 0 0 0 2
8.Secondary Outcome
Title Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
Hide Description [Not Specified]
Time Frame Days 28, 90 and 120 after 1st vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Protocol deviations results in testing not performed for outcome measure.
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description:
Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)
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 vaccine.
 
Arm/Group Title Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Hide Arm/Group Description Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe. TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe. TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe. TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device. TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
All-Cause Mortality
Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%)   0/17 (0.00%)   0/17 (0.00%)   1/16 (6.25%) 
Cardiac disorders           
Cyanosis * 1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Nervous system disorders           
Hypoaesthesia * 1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Neuralgia * 1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Group 1: TDV SC_ 2 Doses Day 0 Group 2: TDV IM_2 Doses Day 0 Group 3: TDV IM_2 Doses Days 0 and 90 Group 4: TDV SC_2 Doses Day 0 Group 5: TDV IM_2 Doses Day 0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/14 (64.29%)   7/16 (43.75%)   10/17 (58.82%)   7/17 (41.18%)   11/16 (68.75%) 
Blood and lymphatic system disorders           
Lymphadenopathy  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Endocrine disorders           
Endocrine disorder  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Hypothyroidism  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Eye disorders           
Conjunctivitis  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Eye pain  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Gastrointestinal disorders           
Abdominal pain  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Diarrhoea  1  1/14 (7.14%)  1/16 (6.25%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Dry mouth  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Dyspepsia  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Gastrooesophageal reflux disease  1  0/14 (0.00%)  2/16 (12.50%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Toothache  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
General disorders           
Asthenia  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Chest pain  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Chills  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Injection site scar  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Pain  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Pyrexia  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Immune system disorders           
Multiple allergies  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  1/17 (5.88%)  0/16 (0.00%) 
Infections and infestations           
Eye infection  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Gastroenteritis viral  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Nasopharyngitis  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Pharyngitis streptococcal  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Sinusitis  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Tooth infection  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Upper respiratory tract infection  1  1/14 (7.14%)  1/16 (6.25%)  2/17 (11.76%)  2/17 (11.76%)  2/16 (12.50%) 
Urinary tract infection  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Vaginitis bacterial  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Viral infection  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications           
Contusion  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Corneal abrasion  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Epicondylitis  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Laceration  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Muscle strain  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Wrist fracture  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Metabolism and nutrition disorders           
Dehydration  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Hyperglycaemia  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Joint swelling  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Myalgia  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Nervous system disorders           
Dizziness  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Headache  1  1/14 (7.14%)  0/16 (0.00%)  1/17 (5.88%)  1/17 (5.88%)  2/16 (12.50%) 
Migraine  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Paraesthesia  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Syncope  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Renal and urinary disorders           
Glycosuria  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Dysmenorrhoea  1  1/14 (7.14%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  1/16 (6.25%) 
Erectile dysfunction  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Cough  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Nasal congestion  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Oropharyngeal pain  1  0/14 (0.00%)  0/16 (0.00%)  2/17 (11.76%)  1/17 (5.88%)  0/16 (0.00%) 
Respiratory tract congestion  1  0/14 (0.00%)  0/16 (0.00%)  2/17 (11.76%)  0/17 (0.00%)  1/16 (6.25%) 
Sinus congestion  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Sneezing  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Tonsillar hypertrophy  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact  1  0/14 (0.00%)  1/16 (6.25%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Ecchymosis  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  2/17 (11.76%)  0/16 (0.00%) 
Hyperkeratosis  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Ingrown hair  1  1/14 (7.14%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  0/16 (0.00%) 
Rash  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Urticaria  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Vascular disorders           
Deep vein thrombosis  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Hot flush  1  0/14 (0.00%)  0/16 (0.00%)  0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Hypertension  1  0/14 (0.00%)  0/16 (0.00%)  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Due to protocol non-compliance issues, sponsor decided to only report safety data.
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.
No publication related to study results will be made without Sponsor’s prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Takeda Study Registration Call Center, Central Contact
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01728792     History of Changes
Other Study ID Numbers: INV-DEN-105
U1111-1181-0251 ( Registry Identifier: WHO )
First Submitted: October 16, 2012
First Posted: November 20, 2012
Results First Submitted: August 30, 2016
Results First Posted: January 4, 2017
Last Update Posted: May 18, 2018