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A Safety and Immunogenicity Trial in Adults 65 Years of Age or Over to Prevent Influenza

NCT00706732 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-07-12

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety of the vaccine and the immune response to the vaccine in healthy adult volunteers 65 years of age or older. Volunteers will be assigned by randomization to receive either the vaccine or an inactive substance (placebo) by injections in the arm on two occasions over one month. The study will last approximately 10 months and will have a total of 7 visits.

Conditions

Interventions

BIOLOGICAL

AVX502

2 doses at 2e8 IU given at T=0 and T=4 weeks via the IM route

BIOLOGICAL

AVX502

2 doses at 2e8 IU given at T=0 and T=4 weeks given via the SC route

BIOLOGICAL

Placebo

2 doses of placebo given at T=0 and T=4 weeks via the IM route

BIOLOGICAL

Placebo

2 doses of placebo given at T=0 and T=4 weeks via the SC route

Sponsors & Collaborators

  • AlphaVax, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Olmsted, Ph.D. · AlphaVax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2008-09-30
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00706732 on ClinicalTrials.gov