Healthy Volunteers Clinical Trial
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
Verified date | April 2024 |
Source | Takeda |
Contact | Takeda Contact |
Phone | +1-877-825-3327 |
medinfoUS[@]takeda.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Takeda |
India,
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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