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A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

NCT00735475 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1268

Last updated 2018-05-23

Study results available
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Summary

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Conditions

Interventions

BIOLOGICAL

CSL Limited Influenza Virus Vaccine (Afluria®)

A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.

BIOLOGICAL

US Licensed Influenza Virus Vaccine (Fluzone®)

A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.

Sponsors & Collaborators

  • Seqirus

    lead INDUSTRY

Principal Investigators

  • Clinical Director Vaccines · Seqirus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-01-31
Completion
2009-06-30

Countries

  • United States

Study Locations

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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 NCT00735475 on ClinicalTrials.gov