Clinical trial NCT06060067: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 480
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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:

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.

Primary outcomes:
measure: Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post Vaccination at Day 1
timeFrame: Within 7 days postvaccination at Day 1
measure: Number of Participants with Solicited Local Injection Site AEs, by Severity Within 7 Days Post Vaccination at Day 90
timeFrame: Within 7 days postvaccination at Day 90
measure: Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1
timeFrame: Within 14 days postvaccination at Day 1
measure: Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90
timeFrame: Within 14 days postvaccination at Day 90
measure: Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1
timeFrame: Within 28 days postvaccination at Day 1
measure: Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90
timeFrame: Within 28 days postvaccination at Day 90
measure: Percentage of Participants with an AE Leading to Participant Withdrawal from Trial
timeFrame: From first vaccination on Day 1 through the end of trial (up to Day 270)
measure: Percentage of Participants with an AE Leading to TDV or Placebo Discontinuation.
timeFrame: From first vaccination on Day 1 through the end of trial (up to Day 270)
measure: Percentage of Participants with a Medically-attended AE (MAAE)
timeFrame: From first vaccination on Day 1 through the end of trial (up to Day 270)
measure: Percentage of Participants with a Serious Adverse Event (SAE)
timeFrame: From first vaccination on Day 1 through the end of trial (up to Day 270)
measure: Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test for Each of the 4 Dengue Virus Serotypes
timeFrame: Day 120 (Month 6)
Secondary outcomes:
measure: Geometric Mean Titers by Microneutralization Test for Each of the 4 Dengue Virus Serotypes
timeFrame: Day 1 and Day 270
measure: Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes
timeFrame: Day 1, Day 120 and Day 270
measure: Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes
timeFrame: Day 1, Day 120 and Day 270
Other outcomes:
Locations:
city: Bangalore
country: India
facility: BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri
state: Karnataka
city: Pudupakkam
country: India
facility: Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam
state: Tamil Nadu
city: Bhubaneshwar
country: India
facility: Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar
city: Kattankulathur
country: India
facility: SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri
city: Kolkata
country: India
facility: IPGME&R and SSKM Hospital, 244 AJC Bose Road
city: Lucknow
country: India
facility: King George's Medical University, Department of Medicine, Chowk
city: Nashik
country: India
facility: Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati
city: New Delhi
country: India
facility: Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center
city: Pune
country: India
facility: KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth
city: Visakhapatnam
country: India
facility: King George Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: