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Long-Term Safety and Antibody Persistence of TDV and the Impact of a Booster Dose

NCT03999996 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 365

Last updated 2025-06-12

Study results available
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Summary

The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.

Conditions

  • Dengue Fever

Interventions

BIOLOGICAL

Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV)

TDV subcutaneous injection

BIOLOGICAL

Placebo

Normal Saline (0.9% NaCl) subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
63 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2024-05-25
Completion
2024-05-25
FDA Drug
Yes

Countries

  • United States
  • Mexico

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03999996 on ClinicalTrials.gov