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Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

NCT00775450 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 807

Last updated 2013-12-31

Study results available
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Summary

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.

Primary Objective:

To describe the safety profile for all subjects.

Secondary Objective:

To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Conditions

  • Influenza
  • Orthomyxovirus Infection
  • Myxovirus Infection

Interventions

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.1 mL, Intradermal

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.5 mL, Intramuscular

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.5 mL, Intramuscular

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.1 mL, Intradermal

BIOLOGICAL

Influenza Virus Vaccine USP Trivalent Types A and B

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · 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
2008-10-31
Primary Completion
2009-06-30
Completion
2009-07-31

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 NCT00775450 on ClinicalTrials.gov