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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1178-6503 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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).
This is an exploratory trial to assess the safety, tolerability and immunogenicity of vaccination with a tetravalent dengue vaccine (TDV) in healthy adults delivered intradermally using the conventional needle/syringe or a needle-free PharmaJet® injector.
Two (2) intradermal injections of either vaccine or placebo will be administered to qualified participants (one in each arm) on Day 0 of the study. A subsequent injection will also be given on Day 90 with either vaccine or placebo (in one arm only).
Participants will be evaluated for safety and dengue neutralizing antibody to all four serotypes. All participants will also be evaluated for injection site reactions and have blood drawn for viremia, neutralizing antibodies, cell mediated immunity and innate immunity.
Participants will be required to participate for approximately 10 months from recruitment and collection of data for primary outcomes (through Day 120) including collection of additional samples for measurement of longer term antibody titers (through Day 270).
This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201000034C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: TDV using PharmaJet® Injector | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDV | Biological | TDV suspension for intradermal administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. | 28 Days after each dose |
| Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | 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. | 28 Days after each dose |
| 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 | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Days 0, 28, 90, 118 and 270 | |
| Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States | ||
| Group Health Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29789238 | Derived | Jackson LA, Rupp R, Papadimitriou A, Wallace D, Raanan M, Moss KJ. A phase 1 study of safety and immunogenicity following intradermal administration of a tetravalent dengue vaccine candidate. Vaccine. 2018 Jun 22;36(27):3976-3983. doi: 10.1016/j.vaccine.2018.05.028. Epub 2018 May 19. |
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | 28 Days after each dose |
Unsolicited Adverse Events: 28 days after either vaccination. Serious Adverse Events: Dose 1 until 28 days after Dose 2 (Up to Day 118).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Events meeting the protocol-specified seriousness criteria were reported as SAEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site haematoma | General disorders | MedDRA version 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Placebo | Drug | Phosphate buffered saline (PBS) |
|
| 14 days after each dose |
| 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 | 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. | 14 days after each dose |
| Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | 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. | 28 Days after each dose |
| Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | 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. | 118 Days |
| Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | 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 28 |
| Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | 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 118 |
| Percentage of Participants With Unsolicited Vaccine-Related SAEs | 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. | Dose 1 until 28 days after Dose 2 (Up to Day 118) |
| Days 90 and 270 |
| Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | 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. | Day 0 to Day 104 |
| Seattle |
| Washington |
| 98101 |
| United States |
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Seropositivity Status at Baseline | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
| Primary | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | 28 Days after each dose |
|
|
|
| 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 | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | 14 days after each dose |
|
|
|
| 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 | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | 14 days after each dose |
|
|
|
| Primary | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | 28 Days after each dose |
|
|
|
| Primary | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | 118 Days |
|
|
|
| Primary | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | 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. | Per Protocol Set included all randomized participants who completed the study without any major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28 |
|
|
|
| Primary | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | 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. | Per Protocol Set included all randomized participants who completed the study without any major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 118 |
|
|
|
| Secondary | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Per Protocol Set included all randomized participants who completed the study without any major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 0, 28, 90, 118 and 270 |
|
|
|
| Secondary | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at 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. | Per Protocol Set included all randomized participants who completed the study without any major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 90 and 270 |
|
|
|
| Secondary | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | 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. | Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received. | Posted | Number | percentage of participants | Day 0 to Day 104 |
|
|
|
| Primary | Percentage of Participants With Unsolicited Vaccine-Related SAEs | 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. | Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose. | Posted | Number | percentage of participants | Dose 1 until 28 days after Dose 2 (Up to Day 118) |
|
|
|
| 0 |
| 18 |
| 15 |
| 18 |
| EG001 | 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. | 0 | 17 | 13 | 17 |
| EG002 | 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. | 0 | 17 | 15 | 17 |
| EG003 | 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. | 0 | 15 | 12 | 15 |
| Injection site warmth | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA version 14.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA version 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA version 14.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA version 14.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA version 14.0 | Systematic Assessment |
|
| Occult blood | Investigations | MedDRA version 14.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor is permitted to protect any proprietary information and to provide comments based on information from other studies that may not be available to the Investigator.
| Grade 1 (Mild) |
|
| Grade 2 (Moderate) |
|
| Grade 3 (Severe) |
|
| Grade 4 (Life Threatening) |
|
| Temperature, Any Severity >Grade 0 |
|
| Temperature, Grade 1 (Mild) |
|
| Temperature, Grade 2 (Moderate) |
|
| Headache, Grade 0 (None) |
|
| Headache, Any Severity >Grade 0 |
|
| Headache, Grade 1 (Mild) |
|
| Headache, Grade 2 (Moderate) |
|
| Muscle Pain, Grade 0 (None) |
|
| Muscle Pain, Any Severity >Grade 0 |
|
| Muscle Pain, Grade 1 (Mild) |
|
| Muscle Pain, Grade 2 (Moderate) |
|
| Joint Pain, Grade 0 (None) |
|
| Joint Pain, Any Severity >Grade 0 |
|
| Joint Pain, Grade 1 (Mild) |
|
| Joint Pain, Grade 2 (Moderate) |
|
| Eye Pain, Grade 0 (None) |
|
| Eye Pain, Any Severity >Grade 0 |
|
| Eye Pain, Grade 1 (Mild) |
|
| Increased Sensitivity to Light, Grade 0 |
|
| Increased Sensitivity to Light, Severity >Grade 0 |
|
| Increased Sensitivity to Light, Grade 1 (Mild) |
|
| Increased Sensitivity to Light, Grade 2 (Moderate) |
|
| Tiredness, Grade 0 (None) |
|
| Tiredness, Any Severity >Grade 0 |
|
| Tiredness, Grade 1 (Mild) |
|
| Tiredness, Grade 2 (Moderate) |
|
| Rash Anywhere on Body, Grade 0 (None) |
|
| Rash Anywhere on Body, Any Severity >Grade 0 |
|
| Rash Anywhere on Body, Grade 1 (Mild) |
|
| Rash Anywhere on Body, Grade 2 (Moderate) |
|
| Nausea, Grade 0 (None) |
|
| Nausea, Any Severity >Grade 0 |
|
| Nausea, Grade 1 (Mild) |
|
| Vomiting, Grade 0 (None) |
|
| Vomiting, Any Severity >Grade 0 |
|
| Vomiting, Grade 1 (Mild) |
|
| Swelling, Any Severity >Grade 0 |
|
| Swelling, Grade 1 (Mild) |
|
| Swelling, Grade 2 (Moderate) |
|
| Redness, Grade 0 |
|
| Redness, Any Severity >Grade 0 |
|
| Redness, Grade 1 (Mild) |
|
| Redness, Grade 2 (Moderate) |
|
| Redness, Grade 3 (Severe) |
|
| Itching, Grade 0 (None) |
|
| Itching, Any Severity >Grade 0 |
|
| Itching, Grade 1 (Mild) |
|
| Itching, Grade 2 (Moderate) |
|
| Pain, Grade 0 (None) |
|
| Pain, Any Severity >Grade 0 |
|
| Pain, Grade 1 (Mild) |
|
| Grade 1 (Mild) |
|
| Grade 2 (Moderate) |
|
| Grade 3 (Severe) |
|
| Aspartate aminotransferase increased |
|
| Blood bilirubin increased |
|
| Blood creatine phosphokinase increased |
|
| Occult blood |
|
| DEN-2 |
|
| DEN-3 |
|
| DEN-4 |
|
| DEN-2 |
|
| DEN-3 |
|
| DEN-4 |
|
| Day 0 DEN-2 |
|
| Day 0 DEN-3 |
|
| Day 0 DEN-4 |
|
| Day 28 DEN-1 |
|
| Day 28 DEN-2 |
|
| Day 28 DEN-3 |
|
| Day 28 DEN-4 |
|
| Day 90 DEN-1 |
|
| Day 90 DEN-2 |
|
| Day 90 DEN-3 |
|
| Day 90 DEN-4 |
|
| Day 118 DEN-1 |
|
| Day 118 DEN-2 |
|
| Day 118 DEN-3 |
|
| Day 118 DEN-4 |
|
| Day 270 DEN-1 |
|
| Day 270 DEN-2 |
|
| Day 270 DEN-3 |
|
| Day 270 DEN-4 |
|
| Day 90 DEN-2 |
|
| Day 90 DEN-3 |
|
| Day 90 DEN-4 |
|
| Day 270 DEN-1 |
|
| Day 270 DEN-2 |
|
| Day 270 DEN-3 |
|
| Day 270 DEN-4 |
|
| DEN-2 |
|
| DEN-3 |
|
| DEN-4 |
|