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Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

NCT00388583 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 817

Last updated 2012-04-18

Study results available
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Summary

As a result of the safety and immunogenicity data generated from earlier dose-ranging studies, the present formulation has been selected for further development in the elderly.

Primary Objective:

To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone®.

Secondary Objectives:

Immunogenicity:

To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®.

Safety:

To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.

Conditions

  • Orthomyxoviridae Infection
  • Influenza
  • Myxovirus Infection

Interventions

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine

0.1 mL, Intradermal

BIOLOGICAL

Split, Inactivated, Trivalent Influenza Vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2007-06-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT00388583 on ClinicalTrials.gov