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Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine

NCT03525119 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2022-08-19

Study results available
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Summary

The purpose of this study is to investigate the immunogenicity and safety of the concomitant administration of TDV (subcutaneous \[SC\] injection) and of hepatitis A virus (HAV) vaccine (intramuscular \[IM\] injection) in healthy participants aged 18 to 60 years living in country(ies) non-endemic for both dengue and hepatitis.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

TDV

TDV SC injection

BIOLOGICAL

HAV Vaccine

HAV Vaccine IM injection.

BIOLOGICAL

TDV Placebo

Placebo-matching (normal saline (0.9% NaCl) SC injection.

BIOLOGICAL

HAV Vaccine Placebo

Placebo-matching (normal saline (0.9% NaCl) IM injection.

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-05-16
Primary Completion
2018-10-03
Completion
2019-07-09

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT03525119 on ClinicalTrials.gov