A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

NCT06060067 | Completed Phase 3 Results DMC

• 2 other identifiers: DEN-3022023-000134-15
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 10

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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (16)

• Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years

  Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age).

  Within 7 days post-vaccination at Day 1

• Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over

  Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).

  Within 7 days post-vaccination at Day 1

• Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years

  Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age).

  Within 7 days post-vaccination at Day 90

• Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over

  Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age).

  Within 7 days post-vaccination at Day 90

• Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years

  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 comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).

  Within 14 days post-vaccination at Day 1

• Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over

  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/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).

  Within 14 days post-vaccination at Day 1

• Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years

  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 comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure.

  Within 14 days post-vaccination at Day 90

• Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years

  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 also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure.

  Within 14 days post-vaccination at Day 90

• Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over

  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/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated).

  Within 14 days post-vaccination 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.

  Within 28 days post-vaccination 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.

  Within 28 days post-vaccination 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.

  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.

  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.

  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.

  From first vaccination on Day 1 through the end of trial (up to Day 270)

• GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120

  GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4.

  Day 120 (Month 4)

Secondary Outcomes (3)

• GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270

  Day 1 and 270

• Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes

  Day 1, Day 120 and Day 270

• Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes

  Day 1, Day 120 and Day 270

Study Arms (4)

Cohort 1: ≥18 to ≤60 Years Age Group: TDV

EXPERIMENTAL

Participants received TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

Biological: TDV

Cohort 1: ≥18 to ≤60 Years Age Group: Placebo

PLACEBO COMPARATOR

Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

Biological: Placebo

Cohort 2: ≥4 to <18 Years Age Group: TDV

EXPERIMENTAL

Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

Biological: TDV

Cohort 2: ≥4 to <18 Years Age Group: Placebo

PLACEBO COMPARATOR

Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

Biological: Placebo

Interventions

TDV BIOLOGICAL

TDV SC injection on Day 1 and Day 90 of the study

Also known as: TAK-003

Cohort 1: ≥18 to ≤60 Years Age Group: TDV; Cohort 2: ≥4 to <18 Years Age Group: TDV

Placebo BIOLOGICAL

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

Cohort 1: ≥18 to ≤60 Years Age Group: Placebo; Cohort 2: ≥4 to <18 Years Age Group: Placebo

Eligibility Criteria

• Age: 4 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Participants who can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (10)

BGS Global Institute of Medical Sciences (BGS-GIMS) #67, BGS Health & Education City, Uttarahalli Main Road, Kengeri

Bangalore, Karnataka, 560060, India

Location

Chettinad Academy of Research and Education, Chettinad Health City, SH,49A, Dist. Kelambakkam

Pudupākkam, Tamil Nadu, 603 103, India

Location

Preventive and Therapeutic Clinical Trial Unit (PTCTU), Dept. of Community Medicine, Institute of Medical Science and SUM Hospital, K-8, Kalinga Nagar

Bhubaneswar, 751003, India

Location

SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri

Kattankulathur, 603203, India

Location

IPGME&R and SSKM Hospital, 244 AJC Bose Road

Kolkata, 700020, India

Location

King George's Medical University, Department of Medicine, Chowk

Lucknow, 226003, India

Location

Suyog Hospital, 2nd Floor, B-Wing, Krushi Utpanna Bazar, Samiti Sankul, Dindori Rd, Panchavati

Nashik, 422003, India

Location

Maulana Azad Medical College & Associated Lok Nayak, Govind Ballabh Pant Hospitals and Guru Nanak Eye Center

New Delhi, 110002, India

Location

KEM Hospital Research Centre, Sandar Moodliar Road, Rasta Peth

Pune, 411011, India

Location

King George Hospital

Visakhapatnam, 530002, India

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: March 29, 2024
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: May 29, 2026
• Results First Posted: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

IN (10)