Phase 3 N=480 Randomized Double-blind Prevention

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

Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT06060067 ↗

Enrolled (actual)

480

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: 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 — 42; 10; 4; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: TDV (Biological); Placebo (Biological)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: Takeda
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	42; 10; 4; 4; 0; 0	—
PRIMARY 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	152; 53; 119; 42; 25; 7	—
PRIMARY 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	44; 14; 2; 0; 0; 0	—
PRIMARY 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	163; 55; 117; 41; 12; 3	—
PRIMARY Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years	45; 13; 1; 1; 0; 0	—
PRIMARY Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over	165; 54; 127; 45; 11; 6	—
PRIMARY Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years	38; 14; 0; 0; 0; 0	—
PRIMARY 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	46; 14; 0; 0; 0; 0	—
PRIMARY Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over	169; 59; 129; 45; 6; 0	—
PRIMARY Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1	2.2; 1.7; 2.2; 1.7	—
PRIMARY Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90	1.7; 3.4; 4.5; 3.4	—
PRIMARY Percentage of Participants With an AE Leading to Participant Withdrawal From Trial	0.6; 0; 0; 0	—
PRIMARY Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation	0.6; 0; 0; 0	—
PRIMARY Percentage of Participants With a Medically-attended AE (MAAE)	5.0; 3.3; 10.0; 13.3	—
PRIMARY Percentage of Participants With a Serious Adverse Event (SAE)	0.0; 0.0; 0.0; 0.0	—
PRIMARY GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120	3196.9; 676.6; 2968.0; 267.9; 2547.3; 624.2	—
SECONDARY GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270	1038.5; 699.8; 362.0; 223.1; 797.9; 460.1	—
SECONDARY Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes	90.9; 86.4; 82.6; 76.3; 91.5; 83.1	—
SECONDARY Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes	5.7; 5.1; 8.4; 8.5; 2.3; 1.7	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06060067). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.