NCT03341637

Brief Summary

The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 15, 2019

Completed
Last Updated

August 15, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

November 9, 2017

Results QC Date

July 23, 2019

Last Update Submit

July 23, 2019

Conditions

Dengue

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120

    GMTs of neutralizing antibodies were measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.

    One month post second dose (Day 120)

Secondary Outcomes (8)

  • Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270

    Six months post second dose (Day 270)

  • Seropositivity Rates for Each of the 4 Dengue Serotypes

    One month and six months post second dose (Day 120 and Day 270)

  • Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes

    One month and six months post second dose (Day 120 and Day 270)

  • Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity

    Within 7 days after each vaccination

  • Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity

    Within 14 days after each vaccination

  • +3 more secondary outcomes

Study Arms (2)

Tetravalent Dengue Vaccine (TDV)

EXPERIMENTAL

TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose)

Biological: Tetravalent Dengue Vaccine (TDV)

Placebo

PLACEBO COMPARATOR

TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

Biological: Placebo

Interventions

Tetravalent Dengue Vaccine (TDV)BIOLOGICAL

TDV subcutaneous injection

Tetravalent Dengue Vaccine (TDV)
PlaceboBIOLOGICAL

Normal Saline (0.9% NaCl) subcutaneous injection

Placebo

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The participant is aged 12 to 17 years, inclusive;
  • Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
  • The participant/the participant's legally authorized representative (LAR) signs and dates a written, informed consent/assent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
  • Individuals who can comply with trial procedures and are available for the duration of follow-up.

You may not qualify if:

  • Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
  • Known hypersensitivity or allergy to any of the vaccine components.
  • Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
  • Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barre syndrome).
  • History or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participant due to participation in the trial.
  • Has known or suspected impairment/alteration of immune function, including:
  • Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
  • Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0).
  • Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
  • Receipt of immune-stimulants within 60 days prior to Day 1 (M0).
  • Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
  • Human immunodeficiency virus (HIV) infection or HIV-related disease.
  • Genetic immunodeficiency.
  • Has abnormalities of splenic or thymic function.
  • Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Instituto Nacional de Pediatria (INP)

Mexico City, 04530, Mexico

Location

Hospital Infantil de Mexico Federico Gomez

Mexico City, 06720, Mexico

Location

Biodextra, S.A. de C.V.

Mexico City, 09360, Mexico

Location

Mexico Centre for Clinical Research

Mexico City, ZC 03100, Mexico

Location

Centro de Atencion E Investigacion Medica (CAIMED) Mexico DF

Mexico City, Mexico

Location

Related Publications (2)

  • Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.

    PMID: 40099800DERIVED

  • Biswal S, Mendez Galvan JF, Macias Parra M, Galan-Herrera JF, Carrascal Rodriguez MB, Rodriguez Bueno EP, Brose M, Rauscher M, LeFevre I, Wallace D, Borkowski A. Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naive adolescents in Mexico City. Rev Panam Salud Publica. 2021 Jun 11;45:e67. doi: 10.26633/RPSP.2021.67. eCollection 2021.

    PMID: 34131423DERIVED

MeSH Terms

Conditions

Dengue

Interventions

Dengue Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2017

First Posted

November 14, 2017

Study Start

December 14, 2017

Primary Completion

January 26, 2019

Study Completion

January 26, 2019

Last Updated

August 15, 2019

Results First Posted

August 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will share

Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Locations

ME(5)