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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
480
BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri
Bangalore, Karnataka, India
Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam
Pudupākkam, Tamil Nadu, India
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.
Time frame: Within 7 days postvaccination at Day 1
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.
Time frame: Within 7 days postvaccination at Day 90
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.
Time frame: Within 14 days postvaccination at Day 1
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.
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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
KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth
Pune, India
King George Hospital
Visakhapatnam, India
Time frame: Within 14 days postvaccination at Day 90
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.
Time frame: Within 28 days postvaccination at Day 1
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.
Time frame: Within 28 days postvaccination at Day 90
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.
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)
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.
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)
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.
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)
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.
Time frame: From first vaccination on Day 1 through the end of trial (up to Day 270)
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.
Time frame: Day 120 (Month 6)
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.
Time frame: Day 1 and Day 270
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.
Time frame: Day 1, Day 120 and Day 270
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.
Time frame: Day 1, Day 120 and Day 270