Healthy Volunteers
Conditions
Keywords
Prophylactic vaccination
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALTDV
TDV suspension for intradermal administration
DRUGPlacebo
Phosphate buffered saline (PBS)
Sponsors
National Institutes of Health (NIH)
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* In good health as determined by medical history and physical examination (including blood pressure and heart rate). * Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen. * Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception. * Body Mass Index (BMI) ≤ 35 kg/m\^2.
Exclusion criteria
* Any Grade 2 or above abnormality in the screening laboratory tests. * History of Dengue Fever, Japanese Encephalitis, West Nile or Yellow Fever disease. * Seropositivity to dengue or West Nile virus. * Extensive scarring or tattoo (\> 50%) on arms, shoulders, neck face and head. * History of significant dermatologic disease in the last 6 months. * Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the Day 0 or 90 vaccinations. * Any planned travel to dengue endemic areas including the Caribbean, Mexico, Central America, South America or Southeast Asia, during the study period and during the month prior to screening. * Use of systemic corticosteroids therapy within the previous 6 months (at a dose of 0.5 mg/kg/day). Topical prednisone is not permitted if currently in use or used within the last month prior to the first vaccination. * Use of any prescribed medication 7 days before the first injection. * Previous vaccination in a clinical study or with an approved product against Dengue Fever, Yellow Fever and or Japanese Encephalitis. * Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy in the last 6 months. * Planned donation of blood during the period of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Unsolicited Vaccine-Related SAEs | Dose 1 until 28 days after Dose 2 (Up to Day 118) | A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes. |
| Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | 118 Days | The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs. Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention. |
| Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | Day 28 | Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer. |
| Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | Day 118 | Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer. |
| Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | 28 Days after each dose | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=\<15 millimeters (mm), 2=15 to 30 mm and 3=\>30 mm (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. |
| Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | 28 Days after each dose | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade. |
| 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 | 14 days after each dose | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a 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. |
| 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 | 14 days after each dose | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. |
| Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | 28 Days after each dose | An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | 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. |
| Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | Day 0 to Day 104 | A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is \>= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is \>0 but \<3.6. The percentage of participants with positive results is reported. |
| Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Days 0, 28, 90, 118 and 270 | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in the United States from 15 February 2013 (First participant signed Informed Consent Form) to 26 June 2014 (date of last participant's visit/contact).
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 17 |
| 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. | 17 |
| 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. | 15 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: TDV Using PharmaJet® Injector | Group 2: TDV Using PharmaJet® Injector | Group 3: TDV Using Needle and Syringe | Group 4: TDV Using PharmaJet® Injector | Total |
|---|---|---|---|---|---|
| Age, Continuous | 29.3 years STANDARD_DEVIATION 8.47 | 32.4 years STANDARD_DEVIATION 8.87 | 30.1 years STANDARD_DEVIATION 7.9 | 27.5 years STANDARD_DEVIATION 6.84 | 29.9 years STANDARD_DEVIATION 8.1 |
| Body Mass Index (BMI) | 25.89 kg/m^2 STANDARD_DEVIATION 6.458 | 25.73 kg/m^2 STANDARD_DEVIATION 4.516 | 23.66 kg/m^2 STANDARD_DEVIATION 3.406 | 25.93 kg/m^2 STANDARD_DEVIATION 3.743 | 25.29 kg/m^2 STANDARD_DEVIATION 4.733 |
| Height | 174.47 cm STANDARD_DEVIATION 8.934 | 177.58 cm STANDARD_DEVIATION 9.891 | 179.77 cm STANDARD_DEVIATION 8.833 | 169.13 cm STANDARD_DEVIATION 10.593 | 175.41 cm STANDARD_DEVIATION 10.114 |
| Race/Ethnicity, Customized Asian | 1 participants | 1 participants | 2 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants | 0 participants | 0 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 0 participants | 0 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Multi-Racial | 0 participants | 1 participants | 2 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Non-Hispanic | 17 participants | 17 participants | 17 participants | 12 participants | 63 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 13 participants | 14 participants | 13 participants | 12 participants | 52 participants |
| Region of Enrollment United States | 18 participants | 17 participants | 17 participants | 15 participants | 67 participants |
| Seropositivity Status at Baseline Seronegative | 17 participants | 13 participants | 16 participants | 13 participants | 59 participants |
| Seropositivity Status at Baseline Seropositive | 1 participants | 4 participants | 1 participants | 2 participants | 8 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 5 Participants | 9 Participants | 26 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 12 Participants | 6 Participants | 41 Participants |
| Weight | 78.77 kg STANDARD_DEVIATION 20.349 | 81.19 kg STANDARD_DEVIATION 15.673 | 76.72 kg STANDARD_DEVIATION 13.672 | 73.73 kg STANDARD_DEVIATION 8.939 | 77.73 kg STANDARD_DEVIATION 15.354 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 18 | 13 / 17 | 15 / 17 | 12 / 15 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 | 0 / 17 | 0 / 15 |
Outcome results
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.
Time frame: 118 Days
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood creatine phosphokinase increased | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Aspartate aminotransferase increased | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Occult blood | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood bilirubin increased | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Alanine aminotransferase increased | 5.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood bilirubin increased | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood creatine phosphokinase increased | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Occult blood | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Aspartate aminotransferase increased | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Alanine aminotransferase increased | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood bilirubin increased | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Alanine aminotransferase increased | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Aspartate aminotransferase increased | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood creatine phosphokinase increased | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Occult blood | 5.9 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood creatine phosphokinase increased | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Aspartate aminotransferase increased | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Alanine aminotransferase increased | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Blood bilirubin increased | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs) | Occult blood | 0 percentage of participants |
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.
Time frame: 28 Days after each dose
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 0 (None) | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Any Severity >Grade 0 | 83.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 1 (Mild) | 77.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 2 (Moderate) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 0 (None) | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Any Severity >Grade 0 | 88.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 1 (Mild) | 55.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 2 (Moderate) | 33.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 3 (Severe) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 0 (None) | 100.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Any Severity >Grade 0 | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 1 (Mild) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 0 (None) | 38.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Any Severity >Grade 0 | 61.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 1 (Mild) | 61.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Any Severity >Grade 0 | 100.0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 3 (Severe) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 1 (Mild) | 52.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 0 (None) | 88.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 1 (Mild) | 82.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 0 (None) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 1 (Mild) | 23.5 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Any Severity >Grade 0 | 88.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 0 (None) | 41.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 2 (Moderate) | 70.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Any Severity >Grade 0 | 58.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 0 (None) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Any Severity >Grade 0 | 100.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 0 (None) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Any Severity >Grade 0 | 35.3 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 1 (Mild) | 29.4 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 2 (Moderate) | 64.7 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 3 (Severe) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 0 (None) | 76.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 1 (Mild) | 35.3 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Any Severity >Grade 0 | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 1 (Mild) | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 0 (None) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Any Severity >Grade 0 | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 0 (None) | 64.7 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 1 (Mild) | 76.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 2 (Moderate) | 11.8 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 2 (Moderate) | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 2 (Moderate) | 60.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 1 (Mild) | 66.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 0 (None) | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Any Severity >Grade 0 | 46.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 1 (Mild) | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 0 (None) | 53.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Any Severity >Grade 0 | 86.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 0 (None) | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 0 (None) | 80.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Any Severity >Grade 0 | 93.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Any Severity >Grade 0 | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Pain, Grade 1 (Mild) | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Erythema, Grade 3 (Severe) | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Edema, Grade 2 (Moderate) | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff | Itching, Grade 1 (Mild) | 20.0 percentage of participants |
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.
Time frame: 14 days after each dose
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | 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 | Redness, Grade 0 | 22.2 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Swelling, Any Severity >Grade 0 | 50.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 1 (Mild) | 44.4 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 2 (Moderate) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 0 (None) | 50.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Redness, Any Severity >Grade 0 | 77.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Redness, Grade 1 (Mild) | 44.4 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Redness, Grade 2 (Moderate) | 33.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Redness, Grade 3 (Severe) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Itching, Grade 0 (None) | 66.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Itching, Any Severity >Grade 0 | 33.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Itching, Grade 1 (Mild) | 33.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Itching, Grade 2 (Moderate) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Pain, Grade 0 (None) | 72.2 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Pain, Any Severity >Grade 0 | 27.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Pain, Grade 1 (Mild) | 27.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Redness, Any Severity >Grade 0 | 100 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Redness, Grade 3 (Severe) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Pain, Grade 1 (Mild) | 47.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Itching, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Pain, Any Severity >Grade 0 | 47.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Itching, Grade 0 (None) | 82.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 1 (Mild) | 47.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Itching, Any Severity >Grade 0 | 17.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Redness, Grade 0 | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Redness, Grade 1 (Mild) | 29.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 2 (Moderate) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Swelling, Any Severity >Grade 0 | 58.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Itching, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Redness, Grade 2 (Moderate) | 64.7 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Pain, Grade 0 (None) | 52.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 0 (None) | 41.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Redness, Any Severity >Grade 0 | 100.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Redness, Grade 0 | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Pain, Grade 0 (None) | 76.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Redness, Grade 1 (Mild) | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Redness, Grade 2 (Moderate) | 64.7 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Pain, Grade 1 (Mild) | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Redness, Grade 3 (Severe) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Itching, Grade 0 (None) | 47.1 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Pain, Any Severity >Grade 0 | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Itching, Any Severity >Grade 0 | 52.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Itching, Grade 1 (Mild) | 52.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Swelling, Grade 0 (None) | 35.3 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Swelling, Any Severity >Grade 0 | 64.7 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Itching, Grade 2 (Moderate) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Swelling, Grade 1 (Mild) | 47.1 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Swelling, Grade 2 (Moderate) | 17.6 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Pain, Grade 1 (Mild) | 66.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Redness, Grade 2 (Moderate) | 46.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 1 (Mild) | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 0 (None) | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Pain, Grade 0 (None) | 33.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Redness, Grade 1 (Mild) | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Itching, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Swelling, Any Severity >Grade 0 | 60.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Redness, Grade 0 | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Itching, Grade 0 (None) | 73.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Redness, Any Severity >Grade 0 | 80.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Itching, Any Severity >Grade 0 | 26.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Pain, Any Severity >Grade 0 | 66.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Redness, Grade 3 (Severe) | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Swelling, Grade 2 (Moderate) | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Itching, Grade 1 (Mild) | 26.7 percentage of participants |
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.
Time frame: 14 days after each dose
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | 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 | Vomiting, Any Severity >Grade 0 | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Eye Pain, Grade 1 (Mild) | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Eye Pain, Any Severity >Grade 0 | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 1 (Mild) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Nausea, Any Severity >Grade 0 | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Eye Pain, Grade 0 (None) | 88.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 2 (Moderate) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 2 (Moderate) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Nausea, Grade 0 (None) | 83.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 1 (Mild) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Joint Pain, Any Severity >Grade 0 | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 0 (None) | 88.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 2 (Moderate) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Temperature, Any Severity >Grade 0 | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 2 (Moderate) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 1 (Mild) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Headache, Grade 0 (None) | 61.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 0 (None) | 94.4 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Any Severity >Grade 0 | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 0 (None) | 94.4 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Headache, Any Severity >Grade 0 | 38.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Vomiting, Grade 1 (Mild) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 2 (Moderate) | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 1 (Mild) | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Headache, Grade 1 (Mild) | 22.2 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Vomiting, Grade 0 (None) | 94.4 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Tiredness, Any Severity >Grade 0 | 33.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 0 (None) | 66.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Headache, Grade 2 (Moderate) | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Nausea, Grade 1 (Mild) | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 2 (Moderate) | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 1 (Mild) | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 0 (None) | 88.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 1 (Mild) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Severity >Grade 0 | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 0 | 88.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Any Severity >Grade 0 | 11.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 0 (None) | 100.0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Temperature, Any Severity >Grade 0 | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 1 (Mild) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 2 (Moderate) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Headache, Grade 0 (None) | 29.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Headache, Any Severity >Grade 0 | 70.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Headache, Grade 1 (Mild) | 58.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Headache, Grade 2 (Moderate) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 0 (None) | 82.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Any Severity >Grade 0 | 17.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 1 (Mild) | 17.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 0 (None) | 88.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Joint Pain, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Eye Pain, Grade 0 (None) | 94.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Eye Pain, Any Severity >Grade 0 | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Eye Pain, Grade 1 (Mild) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 0 | 88.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Severity >Grade 0 | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 1 (Mild) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 0 (None) | 70.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Tiredness, Any Severity >Grade 0 | 29.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 1 (Mild) | 23.5 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 0 (None) | 88.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 2 (Moderate) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Nausea, Grade 0 (None) | 88.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Nausea, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Nausea, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Vomiting, Grade 0 (None) | 100.0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Vomiting, Any Severity >Grade 0 | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | 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 | Vomiting, Grade 1 (Mild) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Nausea, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Headache, Grade 0 (None) | 41.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Tiredness, Grade 0 (None) | 47.1 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Rash Anywhere on Body, Any Severity >Grade 0 | 17.6 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Increased Sensitivity to Light, Grade 0 | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Headache, Grade 1 (Mild) | 58.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Increased Sensitivity to Light, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Rash Anywhere on Body, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Tiredness, Any Severity >Grade 0 | 52.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Temperature, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Vomiting, Grade 1 (Mild) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Rash Anywhere on Body, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Increased Sensitivity to Light, Severity >Grade 0 | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Joint Pain, Grade 0 (None) | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Headache, Grade 2 (Moderate) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Temperature, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Tiredness, Grade 1 (Mild) | 41.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Joint Pain, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Temperature, Grade 0 (None) | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Muscle Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Vomiting, Any Severity >Grade 0 | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Joint Pain, Grade 1 (Mild) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Headache, Any Severity >Grade 0 | 58.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Increased Sensitivity to Light, Grade 2 (Moderate) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Nausea, Grade 0 (None) | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Joint Pain, Grade 2 (Moderate) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Tiredness, Grade 2 (Moderate) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Muscle Pain, Grade 1 (Mild) | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Nausea, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Eye Pain, Grade 0 (None) | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Muscle Pain, Grade 0 (None) | 76.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Vomiting, Grade 0 (None) | 94.1 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Temperature, Grade 1 (Mild) | 5.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Eye Pain, Any Severity >Grade 0 | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Rash Anywhere on Body, Grade 0 (None) | 82.4 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Muscle Pain, Any Severity >Grade 0 | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | 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 | Eye Pain, Grade 1 (Mild) | 11.8 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Vomiting, Any Severity >Grade 0 | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Eye Pain, Grade 1 (Mild) | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 0 (None) | 60.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 0 | 86.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Nausea, Any Severity >Grade 0 | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Severity >Grade 0 | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Headache, Grade 2 (Moderate) | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Temperature, Any Severity >Grade 0 | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 1 (Mild) | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Increased Sensitivity to Light, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Headache, Grade 1 (Mild) | 46.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 0 (None) | 60.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Nausea, Grade 1 (Mild) | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Tiredness, Any Severity >Grade 0 | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Headache, Any Severity >Grade 0 | 53.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 1 (Mild) | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Vomiting, Grade 1 (Mild) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Tiredness, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Headache, Grade 0 (None) | 46.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 0 (None) | 93.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Vomiting, Grade 0 (None) | 100 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Any Severity >Grade 0 | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 0 (None) | 100.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 1 (Mild) | 6.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Rash Anywhere on Body, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 0 (None) | 86.7 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Temperature, Grade 1 (Mild) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Joint Pain, Any Severity >Grade 0 | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 1 (Mild) | 13.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Grade 1 (Mild) | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Joint Pain, Grade 2 (Moderate) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Nausea, Grade 0 (None) | 93.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Eye Pain, Grade 0 (None) | 93.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Muscle Pain, Any Severity >Grade 0 | 40.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | 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 | Eye Pain, Any Severity >Grade 0 | 6.7 percentage of participants |
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.
Time frame: 28 Days after each dose
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Any Severity | 83.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 1 (Mild) | 22.2 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 4 (Life Threatening) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 3 (Severe) | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 2 (Moderate) | 44.4 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 1 (Mild) | 35.3 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 4 (Life Threatening) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 3 (Severe) | 17.6 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 2 (Moderate) | 23.5 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Any Severity | 76.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Any Severity | 88.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 4 (Life Threatening) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 2 (Moderate) | 17.6 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 1 (Mild) | 52.9 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 3 (Severe) | 5.9 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 4 (Life Threatening) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Any Severity | 80.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 1 (Mild) | 53.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 2 (Moderate) | 20.0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity | Grade 3 (Severe) | 6.7 percentage of participants |
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.
Time frame: 28 Days after each dose
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Any Severity | 16.7 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 1 (Mild) | 11.1 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 2 (Moderate) | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 3 (Severe) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 1 (Mild) | 11.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 2 (Moderate) | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 3 (Severe) | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Any Severity | 17.6 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 2 (Moderate) | 11.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 1 (Mild) | 41.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 3 (Severe) | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Any Severity | 52.9 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 3 (Severe) | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 1 (Mild) | 33.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Any Severity | 33.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity | Grade 2 (Moderate) | 0 percentage of participants |
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.
Time frame: Dose 1 until 28 days after Dose 2 (Up to Day 118)
Population: Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related SAEs | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related SAEs | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Unsolicited Vaccine-Related SAEs | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Unsolicited Vaccine-Related SAEs | 0 percentage of participants |
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.
Time frame: Day 28
Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-1 | 75.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-2 | 62.5 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-3 | 56.3 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-4 | 31.3 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-2 | 61.5 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-3 | 23.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-4 | 23.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-1 | 38.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-3 | 31.3 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-2 | 50.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-4 | 50.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-1 | 62.5 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-4 | 38.5 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-2 | 76.9 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-1 | 84.6 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection | DEN-3 | 46.2 percentage of participants |
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.
Time frame: Day 118
Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-1 | 75.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-2 | 68.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-3 | 75.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-4 | 31.3 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-2 | 69.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-3 | 69.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-4 | 30.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-1 | 69.2 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-3 | 87.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-2 | 62.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-4 | 81.3 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-1 | 87.5 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-4 | 53.8 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-2 | 84.6 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-1 | 84.6 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection | DEN-3 | 84.6 percentage of participants |
Secondary
Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes
Time frame: Days 0, 28, 90, 118 and 270
Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-4 | 7.1 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-2 | 293.4 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-4 | 5.0 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-1 | 5.0 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-2 | 118.1 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-3 | 32.2 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-2 | 160.0 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-3 | 30.2 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-3 | 30.8 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-4 | 13.5 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-3 | 21.8 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-4 | 8.4 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-1 | 16.8 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-1 | 29.5 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-1 | 28.3 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-3 | 5.0 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-1 | 25.9 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-2 | 174.5 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-2 | 5.0 titer |
| Group 1: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-4 | 8.4 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-3 | 5.0 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-3 | 22.3 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-3 | 19.0 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-4 | 11.7 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-3 | 14.5 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-1 | 21.1 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-2 | 220.3 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-4 | 5.0 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-4 | 10.0 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-1 | 10.5 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-2 | 173.3 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-2 | 311.6 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-2 | 5.0 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-3 | 11.1 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-1 | 5.0 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-1 | 12.4 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-4 | 11.7 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-1 | 26.1 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-4 | 10.8 titer |
| Group 2: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-2 | 311.6 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-3 | 36.7 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-1 | 5.0 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-2 | 5.0 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-3 | 5.0 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-4 | 5.0 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-1 | 27.1 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-2 | 146.7 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-3 | 10.0 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-4 | 32.2 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-1 | 28.9 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-2 | 60.4 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-3 | 11.9 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-4 | 20.9 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-1 | 60.4 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-2 | 89.2 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-4 | 54.2 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-1 | 24.8 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-2 | 54.2 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-3 | 14.8 titer |
| Group 3: TDV Using Needle and Syringe | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-4 | 28.3 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-3 | 32.3 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-2 | 560.1 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-1 | 19.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-3 | 14.5 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-4 | 20.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-3 | 19.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-2 | 5.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-1 | 10.5 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-2 | 1006.9 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 28 DEN-1 | 29.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-1 | 5.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-2 | 265.5 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-4 | 5.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 0 DEN-3 | 5.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-1 | 21.1 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 270 DEN-4 | 13.8 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-2 | 429.1 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-4 | 19.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 90 DEN-3 | 19.0 titer |
| Group 4: TDV Using PharmaJet® Injector | Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes | Day 118 DEN-4 | 22.3 titer |
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.
Time frame: Day 0 to Day 104
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-1 | 0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-2 | 38.9 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-3 | 5.6 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-4 | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-2 | 23.5 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-3 | 5.9 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-4 | 0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-1 | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-3 | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-2 | 23.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-4 | 0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-1 | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-4 | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-2 | 53.3 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-1 | 0 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination | DEN-3 | 0 percentage of participants |
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.
Time frame: Days 90 and 270
Population: Per Protocol Set included all randomized participants who completed the study without any major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-1 | 68.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-2 | 75.0 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-3 | 62.5 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-4 | 18.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-1 | 62.5 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-2 | 62.5 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-3 | 68.8 percentage of participants |
| Group 1: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-4 | 25.0 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-2 | 69.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-1 | 46.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-2 | 69.2 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-4 | 23.1 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-3 | 53.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-4 | 30.8 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-3 | 61.5 percentage of participants |
| Group 2: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-1 | 61.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-3 | 75.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-3 | 43.8 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-4 | 56.3 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-1 | 75.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-2 | 50.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-4 | 75.0 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-1 | 62.5 percentage of participants |
| Group 3: TDV Using Needle and Syringe | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-2 | 43.8 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-3 | 61.5 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-4 | 46.2 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-2 | 84.6 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 90 DEN-1 | 76.9 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-1 | 61.5 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-4 | 46.2 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-3 | 69.2 percentage of participants |
| Group 4: TDV Using PharmaJet® Injector | Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270 | Day 270 DEN-2 | 84.6 percentage of participants |