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A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination

NCT00835926 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2016-04-14

Study results available
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Summary

To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

Conditions

Interventions

BIOLOGICAL

Influenza virus vaccine

0.5 mL, Intramuscular

BIOLOGICAL

Influenza virus vaccine

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2003-09-30
Completion
2003-09-30

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 NCT00835926 on ClinicalTrials.gov