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Efficacy Study of an Investigational Influenza Vaccine (Vero Cell Derived) to Prevent Culture Confirmed Influenza Infection (CCII)

NCT00566345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3670

Last updated 2023-10-17

Study results available
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Summary

The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.

Conditions

Interventions

BIOLOGICAL

Inactivated seasonal influenza vaccine (split virus, Vero cell-derived)

Trivalent, non-adjuvanted vaccine; dose: 0.5 ml

OTHER

Phosphate buffered saline

Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml

Sponsors & Collaborators

  • Alachua Government Services, Inc.

    lead INDUSTRY

Principal Investigators

  • Karen Near, MD · Baxter Healthcare Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00566345 on ClinicalTrials.gov