Back to resultsLong-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Primary Purpose
Dengue Fever
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Dengue Fever focused on measuring Vaccine
Eligibility Criteria
Inclusion Criteria:
1. Male or female participants (irrespective of serostatus at Baseline in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]) who received at least one dose of Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials and have data from at least one blood draw post-vaccination.
Exclusion Criteria:
- Participants with a prolonged period of habitation (≥1 year) in a dengue endemic area within the 2 years prior to Day 1 (Month 0).
- Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue (other than Takeda's TDV), yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
Booster Criteria:
- Participants for whom Baseline serostatus is not defined in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]).
- Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 24 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); use of inhaled, intranasal, or topical corticosteroids is allowed.
- Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 24 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
- Administration of immunoglobulins and/or any blood products within the 3 months prior to administration of the TDV booster or placebo at Month 24 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); consider whether applicable as an exclusion criterion or criterion for delay.
- Receipt of immunostimulants within 60 days prior to Month 24 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
- Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Month 24 for participants from parent trial DEN-315 (Mexico) / Month 15 for participants from parent trial DEN-304 (US).
- Known human immunodeficiency virus (HIV) infection or HIV-related disease.
- Hepatitis C virus infection.
- Genetic immunodeficiency.
- Abnormalities of splenic or thymic function.
- Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Participants with history of current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a prolonged period of habitation (≥1 year) in a dengue endemic area during trial conduct.
Sites / Locations
- Synexus - Optimal Research - Huntsville
- Synexus - Optimal Research - Peoria
- Heartland Research Associates LLC
- Optimal Research
- Synexus Clinical Research US, Inc. Minneapolis
- Synexus Clinical Research US, Inc. - St. Louis
- Synexus Clinical Research US, Inc. - Omaha
- Advanced Clinical Research - Meridian - ERN-PPDS
- Instituto Nacional de Pediatria
- CAIMED Investigacion en Salud, S. A. de C. V.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Placebo
Arm Description
TDV 0.5 mL, injection, subcutaneously, once at Month 15 for participants from parent trials DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).
TDV placebo-matching 0.5 mL injection, subcutaneously, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).
Outcomes
Primary Outcome Measures
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 0 (Day 1)
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 12
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 15 (US)
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 42 (Mexico)
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 0 (Day 1)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 12
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 15 (US)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 42 (Mexico)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose at Month 0 (Day 1)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose at Month 12
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose Month 15 (US)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose at Month 42 (Mexico)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 43 (Mexico)
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 21 (US)
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 48 (Mexico)
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 43 (Mexico)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 21 (US)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 48 (Mexico)
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 1 Month Post-Booster Dose at Month 43 (Mexico)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Month 21 (US)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose at Month 48 (Mexico)
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Secondary Outcome Measures
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for all Participants Prior to the Booster Dose
GMR of neutralizing antibodies will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trial (DEN-304 and DEN-315).
GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Post-booster Dose
GMR of neutralizing antibodies will be calculated for participants randomized to Groups 1 and 2 by current trial group, by current trial group and parent trial (DEN-304 and DEN-315), and by trial group and serostatus at baseline in the parent trial (DEN-304 and DEN-315).
Percentage of Participants with Solicited Local Injection Site Adverse Events (AEs) by Severity, Post-booster Dose
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days post-booster dose at Month 15 (US) and Month 42 (Mexico).
Percentage of Participants with Solicited Systemic AEs by Severity Post-booster Dose
Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days post-booster dose at Month 15 (US) and Month 42 (Mexico).
Percentage of Participants with any Unsolicited AEs Post-booster Dose
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants with any Medically Attended AEs (MAAEs) Post-booster Dose
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.
Percentage of Participants with any Serious Adverse Events (SAEs) Prior to the Booster Dose
A SAE is defined as 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 any SAEs Post-Booster Dose
A SAE is defined as 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03999996
Brief Title
Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
Official Title
A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and the Impact of a Booster Dose of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Areas Non-Endemic for Dengue
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
April 10, 2024 (Anticipated)
Study Completion Date
April 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States [US]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
Detailed Description
The vaccine tested in this study is Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV). This study will look at the long-term antibody persistence and safety of Takeda's TDV in healthy adolescents and adults and will assess the impact of a booster dose.
The study has enrolled 365 healthy participants. Participants who previously received TDV in two parent trials (DEN-304 [NCT03423173] and DEN-315 [NCT03341637]), will be invited to participate in this follow-up trial. Participants will be assessed for antibody persistence and safety from Baseline (Month 0) through Month 15 (for participants from parent trial DEN-304 [US]) or Month 42 (for participants from parent trial DEN-315 [Mexico]). At Month 15 (for participants from parent trial DEN-304 [US]) or at Month 42 (for participants from parent trial DEN-315 [Mexico]), eligible participants will be randomized in 1:1 ratio to one of two trial groups to receive TDV or placebo:
A. Group 1- TDV 0.5 mL subcutaneous (SC) injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico]).
B. Group 2- Takeda's tetravalent dengue placebo (dummy SC injection - this is a liquid that looks like the study drug but has no active ingredient), 0.5 mL, subcutaneous injection at Month 15 for participants from parent trial DEN-304 (US) or at Month 42 for participants from parent trial DEN-315 (Mexico).
This multi-centre trial will be conducted in US and Mexico. The overall time to participate in this study is up to 21 months for parent trial DEN-304 (US) and up to 48 months for parent trial DEN-315 (Mexico). Participants from parent trial DEN-304 (US) and participants from parent trial DEN-315 (Mexico) will come for 5 visits to the clinic which includes a final visit (Visit 5) 6 months after the booster dose for a follow-up assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever
Keywords
Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be double-blinded, randomized, and placebo-controlled from Month 15 onwards for participants from parent trial DEN-304 (US) and from Month 42 onwards for participants from parent trial DEN-315 (Mexico).
Allocation
Randomized
Enrollment
365 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Arm Type
Experimental
Arm Description
TDV 0.5 mL, injection, subcutaneously, once at Month 15 for participants from parent trials DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
TDV placebo-matching 0.5 mL injection, subcutaneously, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).
Intervention Type
Biological
Intervention Name(s)
Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)
Intervention Description
TDV subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Normal Saline (0.9% NaCl) subcutaneous injection
Primary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 0 (Day 1)
Description
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
Month 0 (Day 1)
Title
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 12
Description
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
Month 12
Title
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 15 (US)
Description
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
Month 15 (US)
Title
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 42 (Mexico)
Description
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
Month 42 (Mexico)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 0 (Day 1)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 0 (Day 1)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 12
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 12
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 15 (US)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 15 (US)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes Prior to the Booster Dose at Month 42 (Mexico)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 42 (Mexico)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose at Month 0 (Day 1)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 0 (Day 1)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose at Month 12
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 12
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose Month 15 (US)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 15 (US)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Prior to the Booster Dose at Month 42 (Mexico)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trials (DEN-304 and DEN-315).
Time Frame
Month 42 (Mexico)
Title
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
Description
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post-booster dose at Month 16 (US)
Title
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 43 (Mexico)
Description
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
1 month post-booster dose at Month 43 (Mexico)
Title
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 21 (US)
Description
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
6 months post-booster dose at Month 21 (US)
Title
GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 48 (Mexico)
Description
GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 Dengue Serotypes for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico). The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time Frame
6 months post-booster dose at Month 48 (Mexico)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Time Frame
1 month post-booster dose at Month 16 (US)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Month 43 (Mexico)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Time Frame
1 month post-booster dose at Month 43 (Mexico)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 21 (US)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Time Frame
6 months post-booster dose at Month 21 (US)
Title
Percentage of Participants Seropositive for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Month 48 (Mexico)
Description
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity rate will be calculated for participants from parent trials DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trials DEN-304 (US) and DEN-315 (Mexico).
Time Frame
6 months post-booster dose at Month 48 (Mexico)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Month 16 (US)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Time Frame
1 month post-booster dose at Month 16 (US)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 1 Month Post-Booster Dose at Month 43 (Mexico)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Time Frame
1 month post-booster dose at Month 43 (Mexico)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Month 21 (US)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Time Frame
6 months post-booster dose at Month 21 (US)
Title
Percentage of Participants Seropositive for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose at Month 48 (Mexico)
Description
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Seropositivity rate will be calculated for participants from parent trial DEN-304 (US) and DEN-315 (Mexico) randomized to Groups 1 and 2 by current trial group, and by current trial group and serostatus at baseline in the parent trial DEN-304 (US) and DEN-315 (Mexico).
Time Frame
6 months post-Booster dose at Month 48 (Mexico)
Secondary Outcome Measure Information:
Title
Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for all Participants Prior to the Booster Dose
Description
GMR of neutralizing antibodies will be calculated for all participants, for all participants by parent trial (DEN-304 and DEN-315), and for all participants by serostatus at baseline in the parent trial (DEN-304 and DEN-315).
Time Frame
Month 0 vs Month 12 in the current trial, Month 4 in the parent trials vs Month 15 (US) and Month 42 (Mexico) in the current trials, Month 9 in the parent trials vs Month 0 and Month 12 in the current trial
Title
GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes Post-booster Dose
Description
GMR of neutralizing antibodies will be calculated for participants randomized to Groups 1 and 2 by current trial group, by current trial group and parent trial (DEN-304 and DEN-315), and by trial group and serostatus at baseline in the parent trial (DEN-304 and DEN-315).
Time Frame
Month 4 in the parent trials vs 1 and 6 months post-booster dose in the current trial; Month 15 (US)/Month 42 (Mexico) vs 1 month post-booster dose; Month 15 (US)/Month 42 (Mexico) vs 6 month post-booster dose; 1 vs 6 month post-booster dose
Title
Percentage of Participants with Solicited Local Injection Site Adverse Events (AEs) by Severity, Post-booster Dose
Description
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days post-booster dose at Month 15 (US) and Month 42 (Mexico).
Time Frame
Days 1 through 7 post-booster dose at Month 15 (US) and Month 42 (Mexico)
Title
Percentage of Participants with Solicited Systemic AEs by Severity Post-booster Dose
Description
Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days post-booster dose at Month 15 (US) and Month 42 (Mexico).
Time Frame
Days 1 through 14 post-booster dose at Month 15 (US) and Month 42 (Mexico)
Title
Percentage of Participants with any Unsolicited AEs Post-booster Dose
Description
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment.
Time Frame
Days 1 through 28 post-booster dose at Month 15 (US) and Month 42 (Mexico)
Title
Percentage of Participants with any Medically Attended AEs (MAAEs) Post-booster Dose
Description
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.
Time Frame
Month 15 post-booster dose through Month 21 (US); Month 42 post-booster dose through Month 48 (Mexico)
Title
Percentage of Participants with any Serious Adverse Events (SAEs) Prior to the Booster Dose
Description
A SAE is defined as 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
Month 0 through Month 15 (US) and Month 42 (Mexico)
Title
Percentage of Participants with any SAEs Post-Booster Dose
Description
A SAE is defined as 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
Month 15 post-booster dose after vaccination through Month 21 (US); Month 42 post-booster dose after vaccination through Month 48 (Mexico)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Male or female participants (irrespective of serostatus at baseline in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]) who received at least one dose of Takeda's tetravalent dengue vaccine candidate (TDV) in the parent trials and have data from at least one blood draw post-vaccination.
Exclusion Criteria:
Participants with a prolonged period of habitation (≥1 year) in a dengue endemic area within the 2 years prior to Visit 1 Day 1 (Month 0).
Previous and planned vaccination (during the trial conduct), against any flavivirus including dengue (other than Takeda's TDV), yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
Booster Exclusion Criteria:
Participants for whom baseline serostatus is not defined in the parent trials (DEN-304 [(NCT03423173)] and DEN-315 [NCT03341637]).
Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
Known or suspected impairment/alteration of immune function, including:
Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); use of inhaled, intranasal, or topical corticosteroids is allowed.
Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
Administration of immunoglobulins and/or any blood products within the 3 months prior to administration of the TDV booster or placebo at Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US); consider whether applicable as an exclusion criterion or criterion for delay.
Receipt of immunostimulants within 60 days prior to Month 42 for participants from parent trial DEN-315 (Mexico)/ Month 15 for participants from parent trial DEN-304 (US).
Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Month 42 for participants from parent trial DEN-315 (Mexico) / Month 15 for participants from parent trial DEN-304 (US).
Known human immunodeficiency virus (HIV) infection or HIV-related disease.
Hepatitis C virus infection.
Genetic immunodeficiency.
Abnormalities of splenic or thymic function.
Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Participants with history of current or previous infection with a flavivirus such as dengue, Zika, YF, JE, West Nile fever, tick-borne encephalitis or Murray Valley encephalitis and participants with a prolonged period of habitation (≥1 year) in a dengue endemic area during trial conduct.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Synexus - Optimal Research - Huntsville
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35802
Country
United States
Facility Name
Synexus - Optimal Research - Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Heartland Research Associates LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Optimal Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Synexus Clinical Research US, Inc. Minneapolis
City
Richfield
State/Province
Minnesota
ZIP/Postal Code
55423
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Synexus Clinical Research US, Inc. - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Advanced Clinical Research - Meridian - ERN-PPDS
City
Taylorsville
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Instituto Nacional de Pediatria
City
Mexico City
ZIP/Postal Code
4530
Country
Mexico
Facility Name
CAIMED Investigacion en Salud, S. A. de C. V.
City
Mexico City
ZIP/Postal Code
6760
Country
Mexico
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/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/5f6b603c4db2bf003ab4a33e?idFilter=%5B%22DEN-303%22%5D
Description
To obtain more information about this study, click this link.
Learn more about this trial
Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose
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