MedTrace Logo

A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers

NCT01542632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-07-18

Study results available
· View outcomes & findings →

Summary

A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine.

Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (Day 0)\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (Day 0)\], then on Days 30, 90 and 120.

The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).

Conditions

  • Healthy

Interventions

BIOLOGICAL

Takeda's Tetravalent Dengue Vaccine Candidate (TDV)

TDV subcutaneous injection

BIOLOGICAL

TDV New Formulation

TDV New Formulation subcutaneous injection

DRUG

Placebo

Placebo subcutaneous injection

DRUG

New Formulation Placebo

New Formulation placebo subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Gilad Gordon, MD · Inviragen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-01
Primary Completion
2014-01-01
Completion
2014-01-10

Countries

  • United States

Study Locations

More Related Trials

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 NCT01542632 on ClinicalTrials.gov