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Safety and Immunogenicity Study of a Ross River Virus (RRV) Vaccine

NCT00717834 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-10-09

No results posted yet for this study

Summary

The primary objective of this study is to assess the safety and tolerability of the Ross River Virus (RRV) Vaccine in a healthy young adult population. Other objectives of this study are to assess the immunogenicity of the RRV Vaccine in a healthy young adult population and to identify the optimal dose level of the RRV Vaccine in a healthy young adult population.

Conditions

  • Ross River Virus Disease (RRVD)

Interventions

BIOLOGICAL

Formalin-treated, UV-inactivated, whole-virion, Vero cell-derived, preservative free Ross River Virus (RRV) vaccine with or without an Al(OH)3 adjuvant

Two intramuscular injections of either 1.25 µg, 2.5 µg, 5 µg or 10 µg on Days 0 and 21, with a booster vaccination to follow 180 days after the first.

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-10-31
Completion
2009-10-31

Countries

  • Austria
  • Belgium
  • Netherlands

Study Locations

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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 NCT00717834 on ClinicalTrials.gov