Back to resultsA Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
Primary Purpose
Healthy Volunteers
Status
Not yet recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
TDV
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Volunteers focused on measuring Drug Therapy
Eligibility Criteria
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: A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration. A coronavirus vaccine within 14 days prior to TDV or placebo administration. A vaccine authorized for emergency use within 28 days of TDV or placebo administration. 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: Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment. Participants medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration. NOTE: Other protocol defined Inclusion/exclusion criteria may apply.
Sites / Locations
- Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar
- SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri
- IPGME&R and SSKM Hospital, 244 AJC Bose Road
- King George's Medical University, Department of Medicine, Chowk
- Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati
- Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center
- KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth
- King George Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Cohort 1: ≥18 to ≤60 Age Group: TDV
Cohort 1: ≥18 to ≤60 Age Group: Placebo
Cohort 2: ≥4 to <18 Age Group: TDV
Cohort 2: ≥4 to <18 Age Group: Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post Vaccination at Day 1
Solicited local AEs at injection site are defined as injection site pain, injection site erythema, and injection site swelling. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Number of Participants with Solicited Local Injection Site AEs, by Severity Within 7 Days Post Vaccination at Day 90
Solicited local AEs at injection site are defined as injection site pain, injection site erythema, and injection site swelling. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Number of Participants with Solicited Systemic AEs by Severity Within 14 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. Solicited systemic AEs assessments for children <6 years old include: drowsiness, irritability/fussiness, loss of appetite and fever, and those for children ≥ 6 years old/adolescent/adult include: headache, asthenia, malaise, myalgia and fever. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Number of Participants with Solicited Systemic AEs, by Severity Within 14 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. Solicited systemic AEs assessments for children <6 years old include: drowsiness, irritability/fussiness, loss of appetite and fever, and those for children ≥ 6 years old/adolescent/adult include: headache, asthenia, malaise, myalgia and fever. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
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.
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.
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.
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.
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.
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.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test for Each of the 4 Dengue Virus Serotypes
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
Secondary Outcome Measures
Geometric Mean Titers by Microneutralization Test for Each of the 4 Dengue Virus Serotypes
GMTs of neutralizing antibodies will be 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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06060067
Brief Title
A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 8, 2024 (Anticipated)
Primary Completion Date
November 26, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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:
Cohort 1, ≥18 to ≤60 Age Group: TDV
Cohort 1, ≥18 to ≤60 Age Group: Placebo
Cohort 2, ≥4 to <18 Age Group: TDV
Cohort 2, ≥4 to <18 Age Group: Placebo
This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: ≥18 to ≤60 Age Group: TDV
Arm Type
Experimental
Arm Title
Cohort 1: ≥18 to ≤60 Age Group: Placebo
Arm Type
Placebo Comparator
Arm Title
Cohort 2: ≥4 to <18 Age Group: TDV
Arm Type
Experimental
Arm Title
Cohort 2: ≥4 to <18 Age Group: Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
TDV
Other Intervention Name(s)
TAK-003
Intervention Description
TDV SC injection on Day 1 and Day 90 of the study
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post Vaccination at Day 1
Description
Solicited local AEs at injection site are defined as injection site pain, injection site erythema, and injection site swelling. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time Frame
Within 7 days postvaccination at Day 1
Title
Number of Participants with Solicited Local Injection Site AEs, by Severity Within 7 Days Post Vaccination at Day 90
Description
Solicited local AEs at injection site are defined as injection site pain, injection site erythema, and injection site swelling. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time Frame
Within 7 days postvaccination at Day 90
Title
Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1
Description
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 include: drowsiness, irritability/fussiness, loss of appetite and fever, and those for children ≥ 6 years old/adolescent/adult include: headache, asthenia, malaise, myalgia and fever. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time Frame
Within 14 days postvaccination at Day 1
Title
Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90
Description
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 include: drowsiness, irritability/fussiness, loss of appetite and fever, and those for children ≥ 6 years old/adolescent/adult include: headache, asthenia, malaise, myalgia and fever. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time Frame
Within 14 days postvaccination at Day 90
Title
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1
Description
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.
Time Frame
Within 28 days postvaccination at Day 1
Title
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90
Description
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.
Time Frame
Within 28 days postvaccination at Day 90
Title
Percentage of Participants with an AE Leading to Participant Withdrawal from Trial
Description
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.
Time Frame
From first vaccination on Day 1 through the end of trial (up to Day 270)
Title
Percentage of Participants with an AE Leading to TDV or Placebo Discontinuation.
Description
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.
Time Frame
From first vaccination on Day 1 through the end of trial (up to Day 270)
Title
Percentage of Participants with a Medically-attended AE (MAAE)
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
From first vaccination on Day 1 through the end of trial (up to Day 270)
Title
Percentage of Participants with a Serious Adverse Event (SAE)
Description
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.
Time Frame
From first vaccination on Day 1 through the end of trial (up to Day 270)
Title
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test for Each of the 4 Dengue Virus Serotypes
Description
GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes for all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
Time Frame
Day 120 (Month 6)
Secondary Outcome Measure Information:
Title
Geometric Mean Titers by Microneutralization Test for Each of the 4 Dengue Virus Serotypes
Description
GMTs of neutralizing antibodies will be 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.
Time Frame
Day 1 and Day 270
Title
Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
Description
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.
Time Frame
Day 1, Day 120 and Day 270
Title
Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
Description
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.
Time Frame
Day 1, Day 120 and Day 270
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration.
A coronavirus vaccine within 14 days prior to TDV or placebo administration.
A vaccine authorized for emergency use within 28 days of TDV or placebo administration.
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:
Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment.
Participants medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration.
NOTE: Other protocol defined Inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar
City
Bhubaneshwar
ZIP/Postal Code
751003
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Jyotiranjan Sahoo
Facility Name
SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri
City
Kattankulathur
ZIP/Postal Code
603203
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Satyajit Mohapatra
Facility Name
IPGME&R and SSKM Hospital, 244 AJC Bose Road
City
Kolkata
ZIP/Postal Code
700020
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Anupam Mandal
Facility Name
King George's Medical University, Department of Medicine, Chowk
City
Lucknow
ZIP/Postal Code
226003
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Himanshu Dandu
Facility Name
Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati
City
Nashik
ZIP/Postal Code
422003
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Kailash Jagdish Rathi
Facility Name
Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Raghvendra Singh
Facility Name
KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth
City
Pune
ZIP/Postal Code
411011
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Ashish Ramesh Bavdekar
Facility Name
King George Hospital
City
Visakhapatnam
ZIP/Postal Code
530002
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
First Name & Middle Initial & Last Name & Degree
Raju Gnana Sundara
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/
Learn more about this trial
A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
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