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OpenTrials
Completed

NCT Number: NCT06060067

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

4 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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.

NOTE: Other protocol defined Inclusion/exclusion criteria may apply.

Treatment and study plan

TDV

Biological

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

Other names: TAK-003

Placebo

Biological

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

Primary outcomes

  1. 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

    Time frame: Within 7 days post-vaccination at Day 1

    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).

  2. 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

    Time frame: Within 7 days post-vaccination at Day 1

    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).

  3. 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

    Time frame: Within 7 days post-vaccination at Day 90

    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).

  4. 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

    Time frame: Within 7 days post-vaccination at Day 90

    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).

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

    Time frame: 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 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).

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

    Time frame: 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/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).

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

    Time frame: 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 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.

  8. 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

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

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

    Time frame: 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/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).

  10. Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1

    Time frame: 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.

  11. Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90

    Time frame: 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.

  12. Percentage of Participants With an AE Leading to Participant Withdrawal From Trial

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

    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.

  13. Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation

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

    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.

  14. Percentage of Participants With a Medically-attended AE (MAAE)

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

    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.

  15. Percentage of Participants With a Serious Adverse Event (SAE)

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

    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.

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

    Time frame: Day 120 (Month 4)

    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.

Secondary outcomes

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

    Time frame: Day 1 and 270

    GMTs of neutralizing antibodies were 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.

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

    Time frame: Day 1, Day 120 and Day 270

    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.

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

    Time frame: Day 1, Day 120 and Day 270

    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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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