A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue

Takeda5 sites in 1 country400 target enrollmentDecember 14, 2017

ConditionsDengue

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Dengue
Sponsor: Takeda
Enrollment: 400
Locations: 5
Primary Endpoint: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Detailed Description

The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for dengue. The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to receive: * TDV 0.5 mL subcutaneous injection * Placebo normal saline solution (0.9% NaCl) for injection. In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses (8 subjects discontinued the trial before receiving the second dose). This multi-center trial was conducted in Mexico. The overall time to participate in this study was 270 days. Participants had multiple visits to the clinic including a final visit at Day 270.

Registry

clinicaltrials.gov

Start Date

December 14, 2017

End Date

January 26, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Takeda

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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).

Outcomes

Primary Outcomes

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

Time Frame: One month post second dose (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.

Secondary Outcomes

Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity(Within 14 days after each vaccination)
Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity(Within 7 days after each vaccination)
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 Any Unsolicited Adverse Events (AEs) Following Each Vaccination(Within 28 days after each vaccination)
Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study(From first vaccination (Day 1) through end of study (Day 270))
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study(From first vaccination (Day 1) through end of study (Day 270))