Back to resultsEfficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES)
Primary Purpose
Healthy Volunteers
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Tetravalent Dengue Vaccine (TDV)
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Volunteers focused on measuring Drug therapy
Eligibility Criteria
Inclusion Criteria:
- Is aged 4 to 16 years, inclusive, at the time of randomization.
- Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator.
- The participant and/or the participant's parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Can comply with trial procedures and are available for the duration of follow-up.
Inclusion criteria for Booster Phase:
- Is included in the per-protocol set (PPS) of the trial.
- Was aged 4 to 11 years at the time of randomization in the study (Day 1 [Month 0]).
Exclusion Criteria:
- Has febrile illness (temperature ≥38°C) or moderate or severe acute illness or infection at the time of randomization.
- Has history of or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial.
- Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0).
- Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
- Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine.
- Is first degree relative of individuals involved in trial conduct.
- Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0).
- Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination.
- Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- Identified as an employee of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center.
Exclusion criteria for Booster Phase:
- Receipt of any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1b (Month 0b), or planning to receive any vaccine within 28 days after Day 1b (Month 0b).
- Participation in any clinical trial with another investigational product at any time during participation in this trial or intent to participate in another clinical trial at any time during the conduct of the booster phase of this trial.
Sites / Locations
- Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
- Universidade Federal Do Espirito Santo Hospital Universitario Cassiano Antonio de Moraes HUCAM
- Universidade Federal de Mato Grosso do Sul
- Centro de Estudos e Pesquisa em Molestias Infecciosas LTDA (CPCLIN)
- Centro de Atencion e Investigacion Medica S.A - CAIMED - Aguazul - PPDS-PV
- Centro de Atencion e Investigacion Medica S.A - CAIMED - Yopal - PPDS-PV
- Centro de Atencion e Investigacion Medica S.A. - CAIMED - Acacias - PPDS-PV
- Centro de Estudios em Infectologia Pediatrica SAS (CEIP S.A.S)
- Hospital Maternidad Nuestra Senora de Altagracia
- Caimed Dominicana S.A.S - PPDS-PV
- Universidad Nacional Autonoma de Nicaragua
- Centro De Vacunacion Internacional, S.A. (Cevaxin)
- Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede 24 de Diciembre
- Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede Plaza Carolina
- Centro De Vacunacion Internacional, S.A.(Cevaxin) - La Chorrera
- Dela Salle Health Sciences Institute
- Philippines-AFRIMS Virology Research Unit
- University of the Philippine Manila
- Las Pinas Health Center A
- Las Pinas Health Center D
- Research Institute for Tropical Medicine
- Lady Ridgeway Hospital for Children
- Colombo South Teaching Hospital
- Negombo General Hospital
- Colombo North Teaching Hospital
- The Hospital for Tropical Diseases
- Phramongkutklao Hospital
- Srinagarind Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Tetravalent Dengue Vaccine (TDV) 0.5 mL
Arm Description
Placebo-matching TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3). Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0).
TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3). Participants eligible for Booster Phase received TDV, SC injection, based on the randomization on Day 1 (Month 0).
Outcomes
Primary Outcome Measures
Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
The Vaccine Efficacy is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of vaccine efficacy was assessed using the number of confirmed dengue cases that occurred during Part 1.
Secondary Outcome Measures
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Subset
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Subset
Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination.
Severity of Solicited Systemic Adverse Events (AEs) in the Safety Subset
Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination.
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Subset
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Percentage of Participants With a Seropositive Response for Multiple Dengue Serotypes in the Immunogenicity Subset
Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
GMTs of neutralizing antibodies will be measured via microneutralization test 50% (MNT50). The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02747927
Brief Title
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
Acronym
TIDES
Official Title
Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 7, 2016 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
August 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.
Detailed Description
The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to protect people against dengue fever and to look at long-term safety results. This study will look at the success rate of TDV in preventing dengue fever (vaccine efficacy) and long-term side effects of the vaccine.
The study will be conducted in 5 parts. Part 1 will evaluate vaccine efficacy (VE) and will last a minimum of 15 months. Part 2 will be for an additional 6 months to evaluate VE. Part 3 will evaluate long-term safety by following participants for side effects and will last an additional 3 years. Part 4 will evaluate safety for 13 months post-booster vaccination. Part 5 will be the long-term safety follow-up for 1 year after completion of Part 4. Participants may be enrolled into a dry-run to commence and test febrile surveillance methodology; this dry-run part may be up to 10 months prior to receiving study injection, however, will not be applicable to all trials sites or participants.
Approximately 20,100 participants will be enrolled into the study and randomly assigned (by chance) to one of the two treatment groups-which will remain undisclosed to the participants and study doctors during the study (unless there is an urgent medical need):
TDV 0.5 mL subcutaneous injection
Placebo (dummy inactive subcutaneous injection) - this is a solution that looks like the study drug but has no active ingredient
All participants will receive a single injection of TDV or placebo on Day 1, Day 90. Participation in a booster phase will be offered to approximately 10,500 participants to receive (TDV or placebo) on Day 1b (Day 1 in booster phase). A subset of participants will be asked to record any local symptoms at the injection site (Pain, Erythema and Swelling) in a diary card for 7 days after each injection. The same subset of participants will also be asked to record any systemic symptoms (child <6 years: fever, irritability/fussiness, drowsiness, loss of appetite and child ≥6 years: fever, headache, asthenia, malaise and myalgia) in a diary card for 14 days after each injection.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 7 years excluding the dry-run. Participants will make multiple visits to the clinic and will be contacted at least every week for the entire study duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
Keywords
Drug therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20099 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-matching TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3). Participants eligible for Booster Phase received placebo matching TDV, SC injection, based on the randomization on Day 1 (Month 0).
Arm Title
Tetravalent Dengue Vaccine (TDV) 0.5 mL
Arm Type
Experimental
Arm Description
TDV, 0.5mL, subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3). Participants eligible for Booster Phase received TDV, SC injection, based on the randomization on Day 1 (Month 0).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
TDV placebo-matching SC injection.
Intervention Type
Biological
Intervention Name(s)
Tetravalent Dengue Vaccine (TDV)
Intervention Description
TDV SC injection.
Primary Outcome Measure Information:
Title
Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
Description
The Vaccine Efficacy is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of vaccine efficacy was assessed using the number of confirmed dengue cases that occurred during Part 1.
Time Frame
30 days post-second vaccination (Day 120) until the end of Part 1 (120 cases of dengue fever are confirmed and minimum duration of participant follow-up of 12 months post-second vaccination)
Secondary Outcome Measure Information:
Title
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
Description
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
Time Frame
From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)
Title
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline
Description
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
Time Frame
From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)
Title
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline
Description
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
Time Frame
From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)
Title
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
Description
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
Time Frame
From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)
Title
VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype
Description
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR).
Time Frame
From 30 days post-second vaccination (Day 120) until the end of Part 2 (up to 21 months)
Title
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Subset
Description
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination.
Time Frame
Days 1 through 7 after each vaccination
Title
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Subset
Description
Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination.
Time Frame
Days 1 through 14 after each vaccination
Title
Severity of Solicited Systemic Adverse Events (AEs) in the Safety Subset
Description
Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination.
Time Frame
Days 1 through 14 after each vaccination
Title
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Subset
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Time Frame
Days 1 through 28 after each vaccination
Title
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
Description
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time Frame
From Day 1 until the end of Parts 1 and 2 (approximately 21 months)
Title
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
Description
A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time Frame
First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)
Title
Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Description
Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Time Frame
Prevaccination on Day 1, post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Title
Percentage of Participants With a Seropositive Response for Multiple Dengue Serotypes in the Immunogenicity Subset
Description
Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Time Frame
Prevaccination on Day 1, post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Title
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Description
GMTs of neutralizing antibodies will be measured via microneutralization test 50% (MNT50). The four DENV serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
Time Frame
Prevaccination on Day 1, post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Is aged 4 to 16 years, inclusive, at the time of randomization.
Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator.
The participant and/or the participant's parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
Can comply with trial procedures and are available for the duration of follow-up.
Inclusion criteria for Booster Phase:
Is included in the per-protocol set (PPS) of the trial.
Was aged 4 to 11 years at the time of randomization in the study (Day 1 [Month 0]).
Exclusion Criteria:
Has febrile illness (temperature ≥38°C) or moderate or severe acute illness or infection at the time of randomization.
Has history of or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial.
Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0).
Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine.
Is first degree relative of individuals involved in trial conduct.
Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0).
Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination.
Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily.
Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
Identified as an employee of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center.
Exclusion criteria for Booster Phase:
Receipt of any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1b (Month 0b), or planning to receive any vaccine within 28 days after Day 1b (Month 0b).
Participation in any clinical trial with another investigational product at any time during participation in this trial or intent to participate in another clinical trial at any time during the conduct of the booster phase of this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40415-000
Country
Brazil
Facility Name
Universidade Federal Do Espirito Santo Hospital Universitario Cassiano Antonio de Moraes HUCAM
City
Vitoria
State/Province
Espirito Santo
ZIP/Postal Code
29040-091
Country
Brazil
Facility Name
Universidade Federal de Mato Grosso do Sul
City
Campo Grande
State/Province
Mato Grosso Do Sul
ZIP/Postal Code
79070-900
Country
Brazil
Facility Name
Centro de Estudos e Pesquisa em Molestias Infecciosas LTDA (CPCLIN)
City
Cidade Alta
State/Province
Natal - RN
ZIP/Postal Code
59025-050
Country
Brazil
Facility Name
Centro de Atencion e Investigacion Medica S.A - CAIMED - Aguazul - PPDS-PV
City
Aguazul
State/Province
Casanare
Country
Colombia
Facility Name
Centro de Atencion e Investigacion Medica S.A - CAIMED - Yopal - PPDS-PV
City
Yopal
State/Province
Casanare
Country
Colombia
Facility Name
Centro de Atencion e Investigacion Medica S.A. - CAIMED - Acacias - PPDS-PV
City
Acacias
State/Province
Meta
ZIP/Postal Code
507001
Country
Colombia
Facility Name
Centro de Estudios em Infectologia Pediatrica SAS (CEIP S.A.S)
City
Cali
State/Province
San Fernando
Country
Colombia
Facility Name
Hospital Maternidad Nuestra Senora de Altagracia
City
Santo Domingo
State/Province
Distrito Nacional Santo Domingo
ZIP/Postal Code
10204
Country
Dominican Republic
Facility Name
Caimed Dominicana S.A.S - PPDS-PV
City
Santo Domingo
State/Province
Distrito Nacional Santo Domingo
Country
Dominican Republic
Facility Name
Universidad Nacional Autonoma de Nicaragua
City
Leon
Country
Nicaragua
Facility Name
Centro De Vacunacion Internacional, S.A. (Cevaxin)
City
Ciudad de Panama
ZIP/Postal Code
10662
Country
Panama
Facility Name
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede 24 de Diciembre
City
Panama
Country
Panama
Facility Name
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede Plaza Carolina
City
Panama
Country
Panama
Facility Name
Centro De Vacunacion Internacional, S.A.(Cevaxin) - La Chorrera
City
Panama
Country
Panama
Facility Name
Dela Salle Health Sciences Institute
City
Dasmarinas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Philippines-AFRIMS Virology Research Unit
City
Cebu City
State/Province
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
University of the Philippine Manila
City
Ermita
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Las Pinas Health Center A
City
Las Pinas
Country
Philippines
Facility Name
Las Pinas Health Center D
City
Las Pinas
Country
Philippines
Facility Name
Research Institute for Tropical Medicine
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Lady Ridgeway Hospital for Children
City
Colombo
ZIP/Postal Code
00800
Country
Sri Lanka
Facility Name
Colombo South Teaching Hospital
City
Dehiwala
ZIP/Postal Code
10250
Country
Sri Lanka
Facility Name
Negombo General Hospital
City
Negombo
ZIP/Postal Code
11500
Country
Sri Lanka
Facility Name
Colombo North Teaching Hospital
City
Ragama
ZIP/Postal Code
11010
Country
Sri Lanka
Facility Name
The Hospital for Tropical Diseases
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10270
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
State/Province
Krung Thep Maha Nakhon
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Citations:
PubMed Identifier
34606595
Citation
Rivera L, Biswal S, Saez-Llorens X, Reynales H, Lopez-Medina E, Borja-Tabora C, Bravo L, Sirivichayakul C, Kosalaraksa P, Martinez Vargas L, Yu D, Watanaveeradej V, Espinoza F, Dietze R, Fernando L, Wickramasinghe P, Duarte MoreiraJr E, Fernando AD, Gunasekera D, Luz K, Venancioda Cunha R, Rauscher M, Zent O, Liu M, Hoffman E, LeFevre I, Tricou V, Wallace D, Alera M, Borkowski A. Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003). Clin Infect Dis. 2022 Aug 24;75(1):107-117. doi: 10.1093/cid/ciab864.
Results Reference
derived
PubMed Identifier
32197105
Citation
Biswal S, Borja-Tabora C, Martinez Vargas L, Velasquez H, Theresa Alera M, Sierra V, Johana Rodriguez-Arenales E, Yu D, Wickramasinghe VP, Duarte Moreira E Jr, Fernando AD, Gunasekera D, Kosalaraksa P, Espinoza F, Lopez-Medina E, Bravo L, Tuboi S, Hutagalung Y, Garbes P, Escudero I, Rauscher M, Bizjajeva S, LeFevre I, Borkowski A, Saez-Llorens X, Wallace D; TIDES study group. Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomised, placebo-controlled, phase 3 trial. Lancet. 2020 May 2;395(10234):1423-1433. doi: 10.1016/S0140-6736(20)30414-1. Epub 2020 Mar 17. Erratum In: Lancet. 2020 Apr 4;395(10230):1114.
Results Reference
derived
PubMed Identifier
31693803
Citation
Biswal S, Reynales H, Saez-Llorens X, Lopez P, Borja-Tabora C, Kosalaraksa P, Sirivichayakul C, Watanaveeradej V, Rivera L, Espinoza F, Fernando L, Dietze R, Luz K, Venancio da Cunha R, Jimeno J, Lopez-Medina E, Borkowski A, Brose M, Rauscher M, LeFevre I, Bizjajeva S, Bravo L, Wallace D; TIDES Study Group. Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents. N Engl J Med. 2019 Nov 21;381(21):2009-2019. doi: 10.1056/NEJMoa1903869. Epub 2019 Nov 6.
Results Reference
derived
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b60224db2bf003ab49693?idFilter=%5B%22DEN-301%22%5D
Description
To obtain more information about this study, click this link.
Learn more about this trial
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
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