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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-000134-15 | EudraCT Number |
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The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months.
Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study.
During the study, participants will visit their study clinic 6 times.
The vaccine being tested in this study is called TDV (Live, Attenuated). TDV is being tested to prevent dengue. This study will assess the safety and immunogenicity of TDV in healthy participants.
The study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TDV or placebo- which will remain undisclosed to the participant, and investigator during the study:
This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: ≥18 to ≤60 Years Age Group: TDV | Experimental | Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
|
| Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | Placebo Comparator | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
|
| Cohort 2: ≥4 to <18 Years Age Group: TDV | Experimental | Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
|
| Cohort 2: ≥4 to <18 Years Age Group: Placebo | Placebo Comparator | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDV | Biological | TDV SC injection on Day 1 and Day 90 of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (<6 years of age). | Within 7 days post-vaccination at Day 1 |
| Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age). | Within 7 days post-vaccination at Day 1 |
| Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (<6 years of age). | Within 7 days post-vaccination at Day 90 |
| Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age). |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270 | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. | Day 1 and 270 |
| Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes |
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Key Inclusion Criteria:
1. Participants who can comply with trial procedures and are available for the duration of follow-up.
Key Exclusion Criteria:
At screening and at vaccination:
A body mass index (BMI) ≥35 kg/m^2.
Intent to participate in another clinical trial at any time during the conduct of this trial.
Plans to receive any of the following:
Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation.
Receipt of previous vaccination against dengue virus.
Previous participation in any clinical trial of a dengue candidate vaccine.
At Vaccination:
NOTE: Other protocol defined Inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri | Bangalore | Karnataka | 560060 | India |
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| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Healthy children and adult participants were enrolled in the study in Cohort 1 (greater than or equal to [≥]18 to less than or equal to [≤]60 Years Age Group) and Cohort 2 (≥4 to less than [<]18 Years Age Group) to receive either Dengue Tetravalent Vaccine (TDV) or placebo in a 3:1 ratio.
Participants took part in the study at 10 investigative sites in India from 29 March 2024 to 05 May 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: ≥18 to ≤60 Years Age Group: TDV | Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| FG001 | Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| FG002 | Cohort 2: ≥4 to <18 Years Age Group: TDV | Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| FG003 | Cohort 2: ≥4 to <18 Years Age Group: Placebo | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomized Set included all randomized participants, regardless of whether any dose of the investigational product (IP) was received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: ≥18 to ≤60 Years Age Group: TDV | Participants received Dengue Tetravalent Vaccine (TDV) subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| BG001 | Cohort 1: ≥18 to ≤60 Years Age Group: Placebo |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (<6 years of age). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age <6 years old are reported in this outcome measure. | Posted | Count of Participants | Participants | Within 7 days post-vaccination at Day 1 |
|
All cause mortality and SAE: From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: >=18 to <=60 Age Group: TDV | Participants randomized to receive TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 15, 2023 | May 4, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 9, 2025 | May 4, 2026 | SAP_001.pdf |
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|
| Placebo | Biological | Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study |
|
| Within 7 days post-vaccination at Day 90 |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). | Within 14 days post-vaccination at Day 1 |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). | Within 14 days post-vaccination at Day 1 |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure. | Within 14 days post-vaccination at Day 90 |
| Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure. | Within 14 days post-vaccination at Day 90 |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). | Within 14 days post-vaccination at Day 90 |
| Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Within 28 days post-vaccination at Day 1 |
| Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Within 28 days post-vaccination at Day 90 |
| Percentage of Participants With an AE Leading to Participant Withdrawal From Trial | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | From first vaccination on Day 1 through the end of trial (up to Day 270) |
| Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | From first vaccination on Day 1 through the end of trial (up to Day 270) |
| Percentage of Participants With a Medically-attended AE (MAAE) | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department but not fulfilling seriousness criteria. | From first vaccination on Day 1 through the end of trial (up to Day 270) |
| Percentage of Participants With a Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event. | From first vaccination on Day 1 through the end of trial (up to Day 270) |
| GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120 | GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4. | Day 120 (Month 4) |
Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. |
| Day 1, Day 120 and Day 270 |
| Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes | Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. | Day 1, Day 120 and Day 270 |
| Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam | Pudupākkam | Tamil Nadu | 603 103 | India |
| Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar | Bhubaneswar | 751003 | India |
| SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri | Kattankulathur | 603203 | India |
| IPGME&R and SSKM Hospital, 244 AJC Bose Road | Kolkata | 700020 | India |
| King George's Medical University, Department of Medicine, Chowk | Lucknow | 226003 | India |
| Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati | Nashik | 422003 | India |
| Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center | New Delhi | 110002 | India |
| KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth | Pune | 411011 | India |
| King George Hospital | Visakhapatnam | 530002 | India |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Reason Not Specified |
|
Participants received placebo-matching TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| BG002 | Cohort 2: ≥4 to <18 Years Age Group: TDV | Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| BG003 | Cohort 2: ≥4 to <18 Years Age Group: Placebo | Participants received placebo-matching TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
| OG001 | Cohort 2: ≥4 to <6 Years Age Group: Placebo | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. |
|
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| Primary | Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age ≥6 years old to <18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Within 7 days post-vaccination at Day 1 |
|
|
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| Primary | Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (<6 years of age). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age <6 years old are reported in this outcome measure. | Posted | Count of Participants | Participants | Within 7 days post-vaccination at Day 90 |
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|
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| Primary | Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited local AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age ≥6 years old to <18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Within 7 days post-vaccination at Day 90 |
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| Primary | Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age <6 years old are reported in this outcome measure. | Posted | Count of Participants | Participants | Within 14 days post-vaccination at Day 1 |
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| Primary | Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old. Data for subgroup of age ≥ 6 years old to < 18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Within 14 days post-vaccination at Day 1 |
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| Primary | Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age <6 years old are reported in this outcome measure. Overall number of participants analyzed is the number of participants with data available for analysis for this outcome measure. | Posted | Count of Participants | Participants | Within 14 days post-vaccination at Day 90 |
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| Primary | Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children <6 years old also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age <6 years old are reported in this outcome measure. | Posted | Count of Participants | Participants | Within 14 days post-vaccination at Day 90 |
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| Primary | Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. As prespecified, solicited systemic AEs were graded separately for the subgroups of age <6 years old and age ≥6 years old to <18 years old. Data for subgroup of age ≥6 years old to <18 years old are reported in this outcome measure along with the data for ≥18 to ≤60 age group. Overall number of participants analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Within 14 days post-vaccination at Day 90 |
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| Primary | Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. | Posted | Number | percentage of participants | Within 28 days post-vaccination at Day 1 |
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| Primary | Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. | Posted | Number | percentage of participants | Within 28 days post-vaccination at Day 90 |
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| Primary | Percentage of Participants With an AE Leading to Participant Withdrawal From Trial | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. | Posted | Number | percentage of participants | From first vaccination on Day 1 through the end of trial (up to Day 270) |
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| Primary | Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. | Posted | Number | percentage of participants | From first vaccination on Day 1 through the end of trial (up to Day 270) |
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| Primary | Percentage of Participants With a Medically-attended AE (MAAE) | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department but not fulfilling seriousness criteria. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. | Posted | Number | percentage of participants | From first vaccination on Day 1 through the end of trial (up to Day 270) |
|
|
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| Primary | Percentage of Participants With a Serious Adverse Event (SAE) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event. | Safety Analysis Set included all randomized participants who received at least 1 dose of IP. | Posted | Number | percentage of participants | From first vaccination on Day 1 through the end of trial (up to Day 270) |
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| Primary | GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120 | GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4. | FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories. | Posted | Geometric Mean | Standard Deviation | titers | Day 120 (Month 4) |
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| Secondary | GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270 | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. | FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories at the specified timepoints. | Posted | Geometric Mean | Standard Deviation | titers | Day 1 and 270 |
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| Secondary | Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes | Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. | FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories at the specified timepoints. | Posted | Number | percentage of participants | Day 1, Day 120 and Day 270 |
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| Secondary | Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes | Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. | FAS included all randomized participants who received at least 1 dose of TDV or placebo, and for whom a valid pre dose measurement, and at least 1 valid post dose measurement were received for immunogenicity assessments. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for the specified categories at the specified timepoints. | Posted | Number | percentage of participants | Day 1, Day 120 and Day 270 |
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| 0 |
| 180 |
| 0 |
| 180 |
| 53 |
| 180 |
| EG001 | Cohort 1: >=18 to <=60 Age Group: Placebo | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. | 0 | 60 | 0 | 60 | 19 | 60 |
| EG002 | Cohort 2: >=4 to <18 Age Group: TDV | Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. | 0 | 180 | 0 | 180 | 52 | 180 |
| EG003 | Cohort 2: >=4 to <18 Age Group: Placebo | Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study. | 0 | 60 | 0 | 60 | 15 | 60 |
| Body temperature | Investigations | MedDRA 28.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 28.0 | Systematic Assessment |
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Not provided
Not provided
| Pain: Mild |
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| Pain: Moderate |
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| Pain: Severe |
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| Erythema: None |
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| Erythema: Mild |
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| Erythema: Moderate |
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| Erythema: Severe |
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| Swelling: None |
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| Swelling: Mild |
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| Swelling: Moderate |
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| Swelling: Severe |
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| Pain: Moderate |
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| Pain: Severe |
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| Erythema: None |
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| Erythema: Mild |
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| Erythema: Moderate |
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| Erythema: Severe |
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| Swelling: None |
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| Swelling: Mild |
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| Swelling: Moderate |
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| Swelling: Severe |
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| Pain: Mild |
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| Pain: Moderate |
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| Pain: Severe |
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| Erythema: None |
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| Erythema: Mild |
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| Erythema: Moderate |
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| Erythema: Severe |
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| Swelling: None |
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| Swelling: Mild |
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| Swelling: Moderate |
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| Swelling: Severe |
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| Irritability or Fussiness: Moderate |
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| Irritability or Fussiness: Severe |
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| Drowsiness: None |
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| Drowsiness: Mild |
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| Drowsiness: Moderate |
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| Drowsiness: Severe |
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| Loss of Appetite: None |
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| Loss of Appetite: Mild |
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| Loss of Appetite: Moderate |
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| Loss of Appetite: Severe |
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| Fever: None |
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| Fever: 38.0-<38.5 °C |
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| Fever: 38.5-<39.0 °C |
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| Fever: 39.0-<39.5 °C |
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| Fever: 39.5-<40.0 °C |
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| Fever: 40.0-<40.5 °C |
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| Fever: 40.5-<41.0 °C |
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| Fever: ≥41.0 °C |
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| Headache: Mild |
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| Headache: Moderate |
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| Headache: Severe |
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| Asthenia: None |
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| Asthenia: Mild |
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| Asthenia: Moderate |
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| Asthenia: Severe |
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| Malaise: None |
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| Malaise: Mild |
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| Malaise: Moderate |
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| Malaise: Severe |
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| Myalgia: None |
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| Myalgia: Mild |
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| Myalgia: Moderate |
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| Myalgia: Severe |
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| Fever: None |
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| Fever: 38.0-<38.5 °C |
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| Fever: 38.5-<39.0 °C |
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| Fever: 39.0-<39.5 °C |
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| Fever: 39.5-<40.0 °C |
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| Fever: 40.0-<40.5 °C |
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| Fever: 40.5-<41.0 °C |
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| Fever: ≥41.0 °C |
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| Irritability or Fussiness: Moderate |
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| Irritability or Fussiness: Severe |
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| Drowsiness: None |
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| Drowsiness: Mild |
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| Drowsiness: Moderate |
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| Drowsiness: Severe |
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| Loss of Appetite: None |
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| Loss of Appetite: Mild |
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| Loss of Appetite: Moderate |
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| Loss of Appetite: Severe |
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| Fever: 38.5-<39.0 °C |
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| Fever: 39.0-<39.5 °C |
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| Fever: 39.5-<40.0 °C |
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| Fever: 40.0-<40.5 °C |
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| Fever: 40.5-<41.0 °C |
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| Fever: ≥41.0 °C |
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| Headache: Mild |
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| Headache: Moderate |
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| Headache: Severe |
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| Asthenia: None |
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| Asthenia: Mild |
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| Asthenia: Moderate |
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| Asthenia: Severe |
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| Malaise: None |
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| Malaise: Mild |
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| Malaise: Moderate |
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| Malaise: Severe |
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| Myalgia: None |
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| Myalgia: Mild |
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| Myalgia: Moderate |
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| Myalgia: Severe |
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| Fever: None |
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| Fever: 38.0-<38.5 °C |
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| Fever: 38.5-<39.0 °C |
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| Fever: 39.0-<39.5 °C |
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| Fever: 39.5-<40.0 °C |
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| Fever: 40.0-<40.5 °C |
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| Fever: 40.5-<41.0 °C |
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| Fever: ≥41.0 °C |
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| DENV-2 |
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| DENV-3 |
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| DENV-4 |
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| Day 1: DENV-2 |
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| Day 1: DENV-3 |
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| Day 1: DENV-4 |
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| Day 270: DENV-1 |
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| Day 270: DENV-2 |
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| Day 270: DENV-3 |
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| Day 270: DENV-4 |
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| Day 1: DENV-2 |
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| Day 1: DENV-3 |
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| Day 1: DENV-4 |
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| Day 120: DENV-1 |
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| Day 120: DENV-2 |
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| Day 120: DENV-3 |
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| Day 120: DENV-4 |
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| Day 270: DENV-1 |
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| Day 270: DENV-2 |
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| Day 270: DENV-3 |
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| Day 270: DENV-4 |
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| Day 1: Bivalent |
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| Day 1: Trivalent |
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| Day 1: Tetravalent |
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| Day 120: Monovalent |
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| Day 120: Bivalent |
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| Day 120: Trivalent |
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| Day 120: Tetravalent |
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| Day 270: Monovalent |
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| Day 270: Bivalent |
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| Day 270: Trivalent |
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| Day 270: Tetravalent |
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