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A Phase 1 Safety Study of Dengusiil in Healthy Adults

NCT04035278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-03

No results posted yet for this study

Summary

This is a Phase 1 study to assess safety and tolerability of a single subcutaneous dose of Dengusiil in healthy adults of 18 to 45 years of age. In this study, immune response to Dengusiil will also be assessed over a period of 6 months and vaccine viremia will also be assessed over a period of 12 days after administration of vaccine.

Conditions

  • Prevention of Dengue Fever

Interventions

BIOLOGICAL

Dengusiil

Dengusiil is provided as lyophilized powder to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted vaccine is injected as a single 0.5 mL subcutaneous (SC) dose.

BIOLOGICAL

Placebo

Placebo is supplied as a vial of lyophilized powder containing all the components of the vaccine except dengue virus serotypes (DENV1, 2, 3 and 4) to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted product is injected as a single 0.5 mL subcutaneous (SC) dose.

Sponsors & Collaborators

  • PPD Australia Pty Ltd

    collaborator UNKNOWN

  • Serum Institute of India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • PRASAD KULKARNI, MD · SERUM INSTITUTE OF INDIA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2021-06-11
Completion
2021-06-11

Countries

  • Australia

Study Locations

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Entities

Drugs

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 NCT04035278 on ClinicalTrials.gov