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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06060067
Other study ID # DEN-302
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date March 29, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date April 1, 2025
Est. primary completion date November 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 60 Years
Eligibility 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: 1. A body mass index (BMI) =35 kg/m^2. 2. Intent to participate in another clinical trial at any time during the conduct of this trial. 3. Plans to receive any of the following: 1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration. 2. A coronavirus vaccine within 14 days prior to TDV or placebo administration. 3. A vaccine authorized for emergency use within 28 days of TDV or placebo administration. 4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation. 5. Receipt of previous vaccination against dengue virus. 6. Previous participation in any clinical trial of a dengue candidate vaccine. At Vaccination: 1. Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment. 2. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
TDV
TDV SC injection on Day 1 and Day 90 of the study
Placebo
Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study

Locations

Country Name City State
India BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri Bangalore Karnataka
India Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar Bhubaneshwar
India SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri Kattankulathur
India IPGME&R and SSKM Hospital, 244 AJC Bose Road Kolkata
India King George's Medical University, Department of Medicine, Chowk Lucknow
India Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati Nashik
India Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center New Delhi
India Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam Pudupakkam Tamil Nadu
India KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth Pune
India King George Hospital Visakhapatnam

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 7 days postvaccination at Day 1
Primary 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. Within 7 days postvaccination at Day 90
Primary 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. Within 14 days postvaccination at Day 1
Primary 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. Within 14 days postvaccination at Day 90
Primary Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1 An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Within 28 days postvaccination at Day 1
Primary Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90 An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Within 28 days postvaccination at Day 90
Primary Percentage of Participants with an AE Leading to Participant Withdrawal from Trial An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. From first vaccination on Day 1 through the end of trial (up to Day 270)
Primary Percentage of Participants with an AE Leading to TDV or Placebo Discontinuation. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. From first vaccination on Day 1 through the end of trial (up to Day 270)
Primary Percentage of Participants with a Medically-attended AE (MAAE) MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. From first vaccination on Day 1 through the end of trial (up to Day 270)
Primary Percentage of Participants with a Serious Adverse Event (SAE) An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event. From first vaccination on Day 1 through the end of trial (up to Day 270)
Primary 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. Day 120 (Month 6)
Secondary 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. Day 1 and Day 270
Secondary Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer =10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Day 1, Day 120 and Day 270
Secondary Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer =10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Day 1, Day 120 and Day 270
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