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

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT06060067

Acronym / sponsor ID

DEN-302

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

480 participants (actual)

Lead sponsor

TakedaIndustry (pharma, biotech, devices)

Study start

29 Mar 2024 (actual)

Primary completion

5 May 2025 (actual)

Study completion

5 May 2025 (actual)

First posted

29 Sep 2023 (actual)

Results

Posted 29 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Double blind (participant, investigator)

Number of arms

4

Who may qualify

Ages

4 to 60 years

Sex

All

Healthy volunteers

Accepted

Age groups

Child, Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• 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.Link provided by the sponsor.
• Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

10 sites in 1 country: see every site and its status.